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MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01643850
Recruitment Status : Completed
First Posted : July 18, 2012
Results First Posted : February 27, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pigmented Villonodular Synovitis
PVNS
Giant Cell Tumor of the Tendon Sheath
GCCTS
Tenosynovial Giant Cell Tumor Localized or Diffused Type
GCTS
Interventions Drug: MCS110
Drug: Placebo
Enrollment 36
Recruitment Details Thirty-seven subjects diagnosed with PVNS or GCTTS were evaluated as part of this study. In all, 36 subjects were treated in three parts (Parts A, B and C) of the study, 30 of whom completed the study. At this final analysis, 6 treated subjects had discontinued from the study.
Pre-assignment Details  
Arm/Group Title MCS110 10 mg/kg (PART A) Placebo (PART A) MCS110 10 mg/kg (PART B) Placebo/10mg/kg (PART B) MCS110 3 mg/kg (Part C) MCS110 5 mg/kg (Part C) MCS110 10 mg/kg (Part C) MCS110 3 mg/kg & MCS110 10mg/kg (Part C) MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Hide Arm/Group Description Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again. Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
Period Title: Overall Study
Started 5 2 8 3 3 3 4 4 4
Completed 5 2 7 3 0 3 3 4 3
Not Completed 0 0 1 0 3 0 1 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             0             1             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             1             0             1
Adverse Event             0             0             0             0             1             0             0             0             0
Administrative Problems             0             0             1             0             1             0             0             0             0
Arm/Group Title MCS110 10 mg/kg (PART A) Placebo (PART A) MCS110 10 mg/kg (PART B) Placebo/10mg/kg (PART B) MCS110 3 mg/kg (Part C) MCS110 5 mg/kg (Part C) MCS110 10 mg/kg (Part C) MCS110 3 mg/kg & MCS110 10mg/kg (Part C) MCS110 5 mg/kg & MCS110 10mg/kg (PART C) Total
Hide Arm/Group Description Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again. Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again. Total of all reporting groups
Overall Number of Baseline Participants 5 2 8 3 3 3 4 4 4 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 2 participants 8 participants 3 participants 3 participants 3 participants 4 participants 4 participants 4 participants 36 participants
51.4  (8.96) 30.0  (4.24) 46.3  (10.14) 26.7  (11.59) 45.7  (17.93) 38.0  (21.66) 43.8  (13.38) 46.3  (2.87) 29.0  (6.06) 41.3  (12.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 2 participants 8 participants 3 participants 3 participants 3 participants 4 participants 4 participants 4 participants 36 participants
Female
3
  60.0%
1
  50.0%
6
  75.0%
2
  66.7%
1
  33.3%
1
  33.3%
3
  75.0%
2
  50.0%
3
  75.0%
22
  61.1%
Male
2
  40.0%
1
  50.0%
2
  25.0%
1
  33.3%
2
  66.7%
2
  66.7%
1
  25.0%
2
  50.0%
1
  25.0%
14
  38.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 2 participants 8 participants 3 participants 3 participants 3 participants 4 participants 4 participants 4 participants 36 participants
Caucasian 4 1 8 2 3 3 3 4 3 31
Black 1 0 0 0 0 0 0 0 1 2
Other 0 1 0 1 0 0 1 0 0 3
1.Primary Outcome
Title Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size
Hide Description To assess the efficacy of a single i.v. dose of MCS110 in changing the size of PVNS tumors (as compared to baseline) compared to placebo over 4 weeks evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Analysis Set
Arm/Group Title Placebo (PART ABC4) MCS110 3 mg/kg (PART ABC4) MCS110 5 mg/kg (PART ABC4) MCS110 10 mg/kg (PART ABC4)
Hide Arm/Group Description:
Single dose placebo from PART A and B
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
Single dose MCS110 10 mg/kg
Overall Number of Participants Analyzed 5 7 7 17
Mean (Standard Deviation)
Unit of Measure: mm3
-4222.8  (6284.56) -668.5  (18751.44) -9998.4  (15628.40) -38002.1  (57314.73)
2.Primary Outcome
Title Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size
Hide Description To assess the efficacy of a single i.v. dose of MCS110 in percent change of the PVNS tumor volume at week 4 as compared to baseline and compared to placebo evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients who received at least a single dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Analysis Set
Arm/Group Title Placebo (PART ABC4) MCS110 3 mg/kg (PART ABC4) MCS110 5 mg/kg (PART ABC4) MCS110 10 mg/kg (PART ABC4)
Hide Arm/Group Description:
Single dose placebo from PART A and B
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
Single dose MCS110 10 mg/kg
Overall Number of Participants Analyzed 5 7 7 17
Mean (Standard Deviation)
Unit of Measure: Percentage
-7.7  (5.10) -7.4  (13.21) -24.8  (23.42) -32.6  (16.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (PART ABC4), MCS110 3 mg/kg (PART ABC4)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.915
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.71 to 1.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (PART ABC4), MCS110 5 mg/kg (PART ABC4)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.57 to 1.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (PART ABC4), MCS110 10 mg/kg (PART ABC4)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.52 to 0.91
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size
Hide Description Assessment of maximum efficacy (multiple i.v.monthly doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 & 10 mg/kg or 5 & 10 mg/kg in changing PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Analysis included data starting from 1st dose of MCS110 in all treatment groups of Parts B and C. Part B patients who received placebo as 1st dose, measurement prior to receiving first dose of MCS110, was used as baseline and assessment time-points were adjusted accordingly. For Part C, participants starting treatment with low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and tumor volume reduction was ≤ 45%. Analysis includes data from patients who received at least 2 doses. The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg]
Time Frame Up to 8 weeks post last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Analysis Set
Arm/Group Title MCS110 3 mg/kg (PART C) MCS110 5 mg/kg (PART C) MCS110 10 mg/kg (PART BC) MCS110 3 mg/kg & MCS110 10mg/kg (Part C) MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
Hide Arm/Group Description:
Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Participants received multiple monthly doses of MCS110 10 mg/kg. This included patients who started with single dose placebo, then switched to MCS110 10mg/kg after they switched to MCS110 10mg/kg and had their baseline re-calculated.
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 7 7 15 4 4
Mean (Standard Deviation)
Unit of Measure: mm3
-2450.3  (2721.24) -29164.3  (23286.18) -37015.1  (29297.02) -42420.1  (63812.69) -3571.9  (3612.97)
4.Primary Outcome
Title Percentage Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size
Hide Description To assess the maximum efficacy of multiple monthly i.v. doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 and 10 mg/kg or 5 and 10 mg/kg by percent change in the PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Subjects starting treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from all participants who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
Time Frame Up to 8 weeks post last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Analysis Set
Arm/Group Title MCS110 3 mg/kg (PART BC) MCS110 5 mg/kg (PART BC) MCS110 10 mg/kg (PART BC) MCS110 3 mg/kg & MCS110 10mg/kg (Part BC) MCS110 5 mg/kg & MCS110 10mg/kg (Part BC)
Hide Arm/Group Description:
Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg. This included patients who started with single dose placebo, then switched to MCS110 10mg/kg after they switched to MCS110 10mg/kg and had their baseline re-calculated.
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 7 7 15 4 4
Mean (Standard Deviation)
Unit of Measure: Percentage
-29.7  (33.73) -56.3  (20.31) -55.0  (19.02) -45.8  (40.11) -22.6  (16.21)
5.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Overall incidence of Adverse Events
Time Frame Approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title MCS110 10 mg/kg (PART A) Placebo (PART A) MCS110 10 mg/kg (PART B) Placebo (PART B) MCS110 3 mg/kg (PART C) MCS110 5 mg/kg (PART C) MCS110 10 mg/kg (PART C)
Hide Arm/Group Description:
Participants received a single dose of 10mg/kg on day 1 administered by i.v. infusion.
Participants received single dose placebo to match MCS110 10mg/kg (i.v. infusion)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion) and then continued with monthly administration of MCS110 10 mg/kg. Subset of MCS110 (Part B)
Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
Overall Number of Participants Analyzed 5 2 11 3 7 7 12
Measure Type: Count of Participants
Unit of Measure: Participants
AEs of mild severity
3
  60.0%
1
  50.0%
11
 100.0%
1
  33.3%
7
 100.0%
6
  85.7%
11
  91.7%
AEs of moderate severity
1
  20.0%
1
  50.0%
9
  81.8%
2
  66.7%
4
  57.1%
2
  28.6%
5
  41.7%
AEs of severe severity
0
   0.0%
0
   0.0%
4
  36.4%
0
   0.0%
2
  28.6%
1
  14.3%
4
  33.3%
Study drug related AEs
3
  60.0%
1
  50.0%
10
  90.9%
1
  33.3%
7
 100.0%
5
  71.4%
8
  66.7%
Serious AEs
0
   0.0%
1
  50.0%
2
  18.2%
0
   0.0%
3
  42.9%
1
  14.3%
4
  33.3%
AEs leading to discontinuation
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  28.6%
1
  14.3%
1
   8.3%
6.Secondary Outcome
Title Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC)
Hide Description Pharmacokinetic for a single dose of MCS110 for serum concentration -time curve (AUC).
Time Frame Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set
Arm/Group Title MCS110 10 mg/kg (PART A) MCS110 10 mg/kg (PART B) Placebo/10 mg kg (PART B) MCS110 3 mg/kg (PART C) MCS110 5 mg/kg (PART C) MCS110 mg/kg (PART C)
Hide Arm/Group Description:
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion)and then continued with monthly administration of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Overall Number of Participants Analyzed 5 8 3 6 7 4
Mean (Standard Deviation)
Unit of Measure: h* ng/mL
Day 1 Number Analyzed 5 participants 8 participants 0 participants 6 participants 7 participants 4 participants
75632187  (16664282) 44258092  (6489002) 12900096  (2373049) 14559871  (7783073) 44854588  (9743190)
Day 29 Number Analyzed 0 participants 0 participants 3 participants 0 participants 0 participants 0 participants
838099  (171148)
Day 85 Number Analyzed 0 participants 8 participants 0 participants 0 participants 1 participants 3 participants
256238447  (140220044) 179084.13  (0) 999719  (278619)
Day 112 Number Analyzed 0 participants 0 participants 3 participants 0 participants 0 participants 0 participants
238619590  (63815086)
7.Secondary Outcome
Title Pharmacokinetics of MCS110 Maximum Concentration (Cmax)
Hide Description Pharmacokinetic characterization of a single dose of MCS110 for maximum serum concentration (Cmax)
Time Frame Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set
Arm/Group Title MCS110 10 mg/kg (PART A) MCS110 10 mg/kg (PART B) Placebo/10 mg kg (PART B) MCS110 3 mg/kg (PART C) MCS110 5 mg/kg (PART C) MCS110 mg/kg (PART C)
Hide Arm/Group Description:
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion)and then continued with monthly administration of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Overall Number of Participants Analyzed 5 8 3 6 7 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 Number Analyzed 5 participants 8 participants 0 participants 6 participants 7 participants 3 participants
234800  (40598) 206750  (32745) 66983  (8493) 85914  (15539) 214667  (39119)
Day 29 Number Analyzed 0 participants 0 participants 3 participants 0 participants 0 participants 0 participants
194667  (36828)
Day 85 Number Analyzed 0 participants 7 participants 0 participants 0 participants 2 participants 3 participants
309429  (54464) 97750  (11667) 255000  (30199)
Day 112 Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants 0 participants
239000  (55154)
8.Secondary Outcome
Title Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax)
Hide Description Pharmacokinetic characterization of a single dose of MCS110 for time to maximum concentration (Tmax)
Time Frame Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set
Arm/Group Title MCS110 10 mg/kg (PART A) MCS110 10 mg/kg (PART B) Placebo/10 mg kg (PART B) MCS110 3 mg/kg (PART C) MCS110 5 mg/kg (PART C) MCS110 mg/kg (PART C)
Hide Arm/Group Description:
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion)and then continued with monthly administration of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Overall Number of Participants Analyzed 5 8 3 6 7 4
Median (Full Range)
Unit of Measure: hour (h)
Day 1 Number Analyzed 5 participants 8 participants 0 participants 6 participants 7 participants 4 participants
2.083
(1.083 to 3.083)
1.192
(1 to 5.05)
3.125
(1.083 to 5.083)
5
(0 to 5.033)
4
(1.083 to 5.067)
Day 29 Number Analyzed 0 participants 0 participants 3 participants 0 participants 0 participants 0 participants
1.467
(1 to 1.5)
Day 85 Number Analyzed 0 participants 7 participants 0 participants 0 participants 2 participants 3 participants
1.25
(1 to 5)
3.533
(2.033 to 5.033)
1.233
(1.083 to 5.05)
Day 112 Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants 0 participants
3.1
(1.017 to 5.183)
9.Secondary Outcome
Title Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time
Hide Description Pharmacokinetic characterization of a single dose of MCS110 for evaluation of macrophage-colony stimulating factor (M-CSF) plasma concentrations over time
Time Frame Baseline, Day 1, Day 85, Day 169
Hide Outcome Measure Data
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Pharmacokinetic Analysis Set
Arm/Group Title MCS110 10 mg/kg (PART A) Placebo/MCS110 10mg/kg (PART A) MCS110 10 mg/kg (PART B) Placebo/10 mg kg (PART B) MCS110 3 mg/kg (PART C) MCS110 5 mg/kg (PART C) MCS110 mg/kg (PART C)
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Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
Participants received single dose placebo to match MCS110 10 mg/k
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion)and then continued with monthly administration of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Overall Number of Participants Analyzed 5 2 8 3 6 7 4
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline Number Analyzed 5 participants 2 participants 7 participants 3 participants 6 participants 5 participants 3 participants
4694.0  (1375.40) 4940.0  (650.54) 5767.1  (1159.12) 5056.7  (1769.67) 4778.3  (2078.12) 5420.0  (3126.20) 3360.0  (747.46)
Day 1 Number Analyzed 4 participants 2 participants 8 participants 3 participants 6 participants 7 participants 3 participants
4762.5  (2256.34) 5060.0  (0) 6405.0  (4103.80) 4916.7  (545.19) 4688.3  (1506.46) 5281.4  (2687.57) 4423.3  (1134.43)
Day 85 Number Analyzed 4 participants 2 participants 7 participants 3 participants 1 participants 2 participants 3 participants
1697500.0  (646445.41) 4235.0  (544.47) 4238571.4  (1446575.60) 4526666.7  (1127578.53) 4750000.0  (0) 4060000.0  (0) 4580000.0  (575065.21)
Day 169 Number Analyzed 4 participants 2 participants 8 participants 3 participants 1 participants 1 participants 3 participants
173750.0  (103345.30) 469.0  (1357.65) 5668750.0  (1928829.68) 5360000.0  (1173797.26) 2290000.0  (0) 4090000.0  (0) 5480000.0  (1225724.28)
10.Secondary Outcome
Title Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I).
Hide Description Pharmacodynamic characterization of a single dose of MCS110 by measuring C-terminal telopeptide of Type 1 Collagen peptide (CTX-I), a biomarker of bone resorption. Data measured in participants from three arms: participants from Part A, B and C who received a single dose of 10 mg/kg and had assessment at week 4 (Part ABC4); participants from Part A and B who received placebo ; and participants from Part B and C who received multiple monthly doses of MCS110 (10 mg/kg.) Serum CTX-I data were generated in Part A and Part B. In Part C, samples were collected for serum bone CTX-I analysis. The analysis was not performed, as enough information on compound mode of action was obtained using creatine kinase (CK) and monocytes (hematology) data. Only data from 10mg/kg (single and multiple doses) are available.
Time Frame Baseline, Week 4, Week 24, Week 104
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Pharmacodynamic analysis
Arm/Group Title MCS110 10 mg/kg (PART ABC4) Placebo (PARTS A and B) MCS110 10 mg/kg (PART BC)
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Participants received a single dose of MCS110 10 mg/kg
PART A: Participants received single dose placebo to match MCS110 10mg/kg (i.v. infusion). PART B: Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion) and then continued with monthly administration of MCS110 10 mg/kg.
Participants received multiple monthly doses of MCS110 10 mg/kg. This included patients who started with single dose placebo, then switched to MCS110 10mg/kg after they switched to MCS110 10mg/kg and had their baseline re-calculated.
Overall Number of Participants Analyzed 17 5 17
Median (Full Range)
Unit of Measure: ng/mL
Baseline Number Analyzed 12 participants 5 participants 10 participants
0.3
(0.2 to 0.5)
0.5
(0.4 to 1.0)
0.4
(0.2 to 0.6)
Week 4 Number Analyzed 11 participants 5 participants 10 participants
0.1
(0.0 to 0.1)
0.6
(0.2 to 0.8)
0.1
(0.0 to 0.2)
Week 24 Number Analyzed 0 participants 0 participants 8 participants
0.1
(0.0 to 0.2)
Week 104 Number Analyzed 0 participants 0 participants 5 participants
0.3
(0.2 to 0.8)
11.Secondary Outcome
Title Number of Participants With Negative Anti-MCS110 Antibody
Hide Description To assess the immunogenicity of MCS110 in serum anti-MCS110 antibody concentrations
Time Frame Baseline, throughout the study up to Day 505
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Safety analysis set
Arm/Group Title MCS110 10 mg/kg (PART A) Placebo (PART A) MCS110 10 mg/kg (PART B) Placebo (PART B) MCS110 3 mg/kg (PART C) MCS110 5 mg/kg (Part C) MCS110 10 mg/kg (Part C) MCS110 3 mg/kg & MCS110 10mg/kg (Part C) MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
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Participants received a single dose of 10mg/kg on day 1 administered by regular infusion.
Participants received single dose placebo to match MCS110 10 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion) and then continued with monthly administration of MCS110 10 mg/kg
Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
Overall Number of Participants Analyzed 5 2 8 3 3 4 4 4 4
Measure Type: Number
Unit of Measure: Number of Participants
Baseline Number Analyzed 5 participants 1 participants 8 participants 3 participants 3 participants 3 participants 4 participants 4 participants 4 participants
5 1 8 3 3 3 3 4 4
Day 29 Number Analyzed 4 participants 2 participants 8 participants 3 participants 2 participants 4 participants 4 participants 4 participants 3 participants
4 2 8 3 2 4 4 4 3
Day 85 Number Analyzed 4 participants 2 participants 7 participants 3 participants 1 participants 3 participants 4 participants 3 participants 4 participants
3 2 7 3 1 3 3 3 4
Day 127 Number Analyzed 4 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
3 1
Day 169 Number Analyzed 4 participants 2 participants 7 participants 1 participants 1 participants 3 participants 3 participants 3 participants 4 participants
4 2 7 1 1 3 3 3 4
Day 336 Number Analyzed 0 participants 0 participants 7 participants 0 participants 0 participants 2 participants 0 participants 0 participants 0 participants
7 2
Day 393 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants 4 participants 4 participants 2 participants
1 2 4 4 2
Day 505 Number Analyzed 0 participants 0 participants 8 participants 0 participants 3 participants 4 participants 4 participants 3 participants 2 participants
6 1 4 4 3 2
12.Secondary Outcome
Title Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
Hide Description To assess the clinical response of joint range of motion following a single i.v. dose of MCS110 or placebo as compared to baseline 4 weeks post-dose evaluated in participants, who had a knee tumor, which was the majority of participants (75%). The analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Time Frame Week 4
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Pharmacodynamic Analysis Set
Arm/Group Title Placebo (PART ABC4) MCS110 3 mg/kg (PART ABC4) MCS110 5 mg/kg (PART ABC4) MCS110 10 mg/kg (PART ABC4)
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Single dose placebo from PART A and B
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
Single dose MCS110 10 mg/kg
Overall Number of Participants Analyzed 5 7 7 17
Mean (Standard Deviation)
Unit of Measure: Degree
Knee Extension Number Analyzed 4 participants 3 participants 3 participants 9 participants
-7.3  (4.99) -12.3  (13.65) 1.7  (2.89) -10.3  (26.69)
Knee Flexion Number Analyzed 4 participants 3 participants 3 participants 9 participants
-2.8  (8.85) 3.7  (13.5) 13.7  (19.76) -15.4  (43.13)
13.Secondary Outcome
Title Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
Hide Description To assess the clinical response of joint range of motion following multiple dose treatment with MCS110 3, 5, or 10 mg/kg evaluated in participants with knee tumor, which was the majority of participants (75%). The data presented are changes from baseline in degree. Participants, who started treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
Time Frame Week 24/28, Week 104
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Pharmacodynamic analysis set
Arm/Group Title MCS110 3 mg/kg (Part BC) MCS110 5 mg/kg (Part BC) MCS110 10 mg/kg (Part BC) MCS110 3 mg/kg & MCS110 10mg/kg (PART BC) MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
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Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 7 7 15 4 4
Mean (Standard Deviation)
Unit of Measure: Degree
Week 24/28: Knee extension Number Analyzed 1 participants 1 participants 11 participants 1 participants 3 participants
-10.0  (0.00) 0.0  (0.0) -10.5  (21.36) -26  (0.0) 1  (1.73)
Week 24/28:(Knee Flexion) Number Analyzed 1 participants 1 participants 11 participants 1 participants 3 participants
-2.0  (0.00) 8  (0.00) 9.9  (8.77) 8  (0.0) 53.0  (61.54)
Week 104:(Knee Extension) Number Analyzed 0 participants 1 participants 8 participants 1 participants 2 participants
0  (0) -3.5  (6.07) -28.0  (0.00) 2.5  (3.54)
Week 104: (Knee Flexion) Number Analyzed 0 participants 1 participants 8 participants 1 participants 2 participants
-6  (0) 7.5  (11.56) 10  (0.00) 70.0  (70.71)
14.Secondary Outcome
Title Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Hide Description Measurement of the participant's pain with a 100 mm visual analog scale (VAS) following treatment with MCS110 3, 5, or 10 mg/kg evaluated. Data presented are changes from baseline in degree. Participants were asked to place a line perpendicular to the VAS line at the point that represented her/his pain intensity. Using a ruler, the score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the participants mark, providing a score from 0-100. Analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
Time Frame Baseline, Week 4, Week 12, Week 24, Week 28, Week 40, Week 48, Week 104
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Pharmacodynamic analysis set
Arm/Group Title MCS110 3 mg/kg (PART BC) MCS110 5 mg/kg (PART BC) MCS110 10 mg/kg (PART BC) MCS110 3 mg/kg & MCS110 10 mg/kg (PART BC) MCS110 5 mg/kg & MCS110 10 mg/kg (PART BC)
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Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg. This included patients who started with single dose placebo, then switched to MCS110 10mg/kg after they switched to MCS110 10mg/kg and had their baseline re-calculated.
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 3 3 15 4 4
Mean (Standard Deviation)
Unit of Measure: millimeters (mm)
Baseline Number Analyzed 2 participants 3 participants 15 participants 4 participants 4 participants
32  (4.24) 9.3  (12.74) 28.6  (21.82) 39.3  (28.43) 51.0  (15.64)
Week 4 Number Analyzed 2 participants 3 participants 15 participants 4 participants 4 participants
22.5  (20.51) 4  (5.29) 22.5  (23.87) 32.0  (24.54) 48.5  (30.71)
Week 12 Number Analyzed 1 participants 3 participants 13 participants 4 participants 4 participants
20  (0) 2.7  (3.06) 13.9  (16.01) 27.5  (26.51) 33  (26.72)
Week 24 Number Analyzed 1 participants 1 participants 12 participants 3 participants 4 participants
0  (0) 0  (0) 21.4  (22.07) 8.5  (9.33) 20.3  (28.51)
Week 28 Number Analyzed 3 participants 3 participants 15 participants 4 participants 4 participants
40  (0) 10.7  (17.62) 0  (0) 0  (0) 0  (0)
Week 40 Number Analyzed 1 participants 3 participants 3 participants 4 participants 3 participants
31  (0) 3.7  (5.51) 31.0  (31.38) 22  (15.81) 25.7  (31.56)
Week 48 Number Analyzed 3 participants 3 participants 9 participants 0 participants 0 participants
0  (0) 0  (0) 21.0  (0)
Week 104 Number Analyzed 3 participants 3 participants 11 participants 4 participants 2 participants
0  (0) 16.0  (18.03) 22.4  (24.23) 17.8  (13.02) 25.7  (24.7)
15.Secondary Outcome
Title Time to Relapse
Hide Description Time to relapse describes the time frame from baseline when the tumor volume increases again after the treatment with MCS110. To be considered a relapse tumor volume had to increase greater than 50% of the difference between tumor volume at baseline and the lowest tumor volume measured by MRI. In this assessment the Part B and Part C patients were analyzed separately. N/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.
Time Frame Up to Week 104
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Pharmacodynamic analysis set
Arm/Group Title MCS110 10mg/kg (PART B) MCS110 3 mg/kg (PART C) MCS110 5 mg/kg (PART C) MCS110 10 mg/kg (PART C) MCS110 3/10 mg/kg (PART C) MCS110 5/10 mg/kg (PART C)
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Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/k. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 11 3 3 4 4 4
Mean (Standard Deviation)
Unit of Measure: Days
337.0  (108.89) 454.0  (0) 477.0  (0) 296.0  (103.24) NA [1]   (NA) NA [1]   (NA)
[1]
N/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.
16.Secondary Outcome
Title Time to Surgery
Hide Description Time to surgery describes the time frame from baseline to the time point when participants had surgical removement of PVNS tumor. This could be either residual tumor after the tumor volume was reduced or surgery due to relapse. In this assessment the Part B and Part C patients were analyzed separately. Not Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery.
Time Frame Up to Week 104
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Pharmacodynamic analysis set
Arm/Group Title MCS110 10mg/kg (PART B) MCS110 3 mg/kg (PART C) MCS110 5 mg/kg (PART C) MCS110 10 mg/kg (PART C) MCS110 3/10 mg/kg (PART C) MCS110 5/10 mg/kg (PART C)
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Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/k. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 11 3 3 3 4 4
Mean (Standard Deviation)
Unit of Measure: Days
387.0  (116.25) 0  (0) 0  (0) 231.0  (0) NA [1]   (NA) NA [1]   (NA)
[1]
Not Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery
17.Secondary Outcome
Title Average of Health-Related Quality of Life Questionnaire Score for mHAQ
Hide Description The mHAQ assesses 20 activities in 8 categories related to daily life, which are rated on a 4-point Likert scale. The mHAQ is calculated as the average of the single scores with the following scoring: without difficulty =0; with some difficulty =1; with much difficulty =2; unable to do =3. Total score is between 0 - 3.0. Values <0.3 are considered normal. Data presented include only participants, who received multiple doses of MCS110.
Time Frame up to 104 weeks
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Pharmacodynamic analysis set
Arm/Group Title MCS110 3 mg/kg (PART BC) MCS110 5 mg/kg (PART BC) MCS110 10 mg/kg (Part BC) MCS110 3 mg/kg & MCS110 10mg/kg (PART BC) MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
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Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 3 3 15 4 4
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 2 participants 3 participants 15 participants 4 participants 4 participants
0.3  (0.35) 0.1  (0.22) 0.3  (0.20) 0.3  (0.33) 0.9  (0.52)
Week 104 Number Analyzed 0 participants 3 participants 11 participants 4 participants 3 participants
0.1  (0.14) 0.2  (0.18) 0.1  (0.19) 0.3  (0.25)
18.Secondary Outcome
Title Number of CD14+ Monocytes and Number of CD14 + Monocytes and CD16+ Monocytes
Hide Description Blood samples were collected for the evaluation of CD14+ monocytes (using FACS) and CD14+ CD16+ monocytes. Based on preliminary analysis, the quality of the samples did not allow meaningful conclusions to be drawn. Thus, in Part B, the monocyte sample collection was discontinued.
Time Frame Baseline Up to Week 104
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Pharmacodynamic analysis set
Arm/Group Title MCS110 10 mg/kg (PART A) MCS110 10 mg/kg (PART B) MCS110 3 mg/kg (PART C) MCS110 5 mg/kg (PART C) MCS110 10 mg/kg (PART C) MCS110 3 mg/kg & MCS110 10mg/kg (PART C) MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
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Participants received a single dose of 10mg/kg on day 1 administered by regular infusion.
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/k. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Participants received multiple monthly doses of MCS110 10 mg/kg )
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 3 mg/kg
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
Overall Number of Participants Analyzed 5 8 3 3 4 4 4
Measure Type: Number
Unit of Measure: Number of Monocytes
NA [1]  NA [1]  NA [1]  NA [2]  NA [2]  NA [2]  NA [2] 
[1]
Due to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done.
[2]
Due to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done
19.Secondary Outcome
Title Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Hide Description The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life (QOL), pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Time Frame Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)
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Pharmacodynamic analysis set
Arm/Group Title MCS110 3 mg/kg (PART BC) MCS110 5 mg/kg (PART BC) MCS110 10 mg/kg (Part BC) MCS110 3 mg/kg & MCS110 10mg/kg (PART BC) MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
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Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 3 3 15 4 4
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline-ADL Number Analyzed 2 participants 1 participants 11 participants 1 participants 2 participants
65.4  (3.12) 69.1  (0.00) 77.3  (7.87) 70.6  (0.00) 71.3  (30.16)
Week 4-ADL Number Analyzed 2 participants 1 participants 11 participants 1 participants 2 participants
79.4  (20.8) 91.2  (0.00) 86.5  (10.37) 89.7  (0.00) 76.0  (18.97)
Week 12-ADL Number Analyzed 1 participants 1 participants 10 participants 1 participants 3 participants
72.1  (0.00) 97.1  (0.00) 87.4  (15.10) 94.1  (0.00) 76.5  (23.53)
Week 24-ADL Number Analyzed 1 participants 1 participants 9 participants 1 participants 1 participants
55.9  (0.00) 0  (0) 89.6  (10.75) 79.4  (0) 73.0  (28.83)
Week 28-ADL Number Analyzed 3 participants 3 participants 9 participants 0 participants 0 participants
52.9  (0) 83.8  (0) 0  (0)
Week 40- ADL Number Analyzed 1 participants 1 participants 2 participants 1 participants 2 participants
79.4  (0) 95.6  (0) 73.5  (29.12) 89.7 89.0  (15.6)
Week 48-ADL Number Analyzed 0 participants 0 participants 8 participants 0 participants 0 participants
85.3  (13.50)
Week 72-ADL Number Analyzed 3 participants 1 participants 10 participants 1 participants 2 participants
48.5  (0) 88.2  (0) 78.7  (20.82) 91.2  (0) 100  (0)
Week 104- ADL Number Analyzed 0 participants 1 participants 7 participants 1 participants 2 participants
77.9 93.5  (7.74) 97.1  (0) 87.5  (17.68)
20.Secondary Outcome
Title Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Hide Description The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Time Frame Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)
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Pharmacodynamic analysis set
Arm/Group Title MCS110 3 mg/kg (PART BC) MCS110 5 mg/kg (PART BC) MCS110 10 mg/kg (Part BC) MCS110 3 mg/kg & MCS110 10mg/kg (PART BC) MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
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Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 3 3 15 4 4
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline-Knee Number Analyzed 2 participants 1 participants 11 participants 1 participants 2 participants
15.6  (13.26) 37.5  (0) 29.5  (23.23) 50.0  (0) 40.6  (4.42)
Week 4-Knee Number Analyzed 2 participants 1 participants 11 participants 1 participants 2 participants
31.3  (17.68) 56.3  (0) 43.8  (22.88) 43.8  (0) 45.8  (13.01)
Week 12-Knee Number Analyzed 1 participants 1 participants 10 participants 1 participants 3 participants
37.5  (0) 56.3  (0) 54.4  (28.72) 62.5  (0) 43.8  (16.54)
Week 24-Knee Number Analyzed 1 participants 0 participants 9 participants 1 participants 3 participants
43.8  (0) 50.7  (34.30) 43.8  (0) 41.7  (21.95)
Week 28-Knee Number Analyzed 1 participants 1 participants 9 participants 1 participants 1 participants
12.5  (0) 56.3  (0) 46.9  (0) 68.8  (0) 56.3  (0)
Week 40- Knee Number Analyzed 1 participants 1 participants 2 participants 1 participants 2 participants
37.5  (0) 62.5  (0) 37.5  (0) 50.0  (0) 68.8  (8.84)
Week 48-Knee Number Analyzed 0 participants 0 participants 8 participants 0 participants 0 participants
48.4  (25.61)
Week 72-Knee Number Analyzed 1 participants 1 participants 10 participants 1 participants 1 participants
25.0  (0) 56.3  (0) 45.0  (26.81) 68.8  (0) 68.8  (0)
Week 104- Knee Number Analyzed 0 participants 1 participants 7 participants 1 participants 2 participants
50.0  (0) 59.8  (21.61) 68.8  (0) 62.5  (17.68)
21.Secondary Outcome
Title Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Hide Description The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Time Frame Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)
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Pharmacodynamic analysis set
Arm/Group Title MCS110 3 mg/kg (PART BC) MCS110 5 mg/kg (PART BC) MCS110 10 mg/kg (Part BC) MCS110 3 mg/kg & MCS110 10mg/kg (PART BC) MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Hide Arm/Group Description:
Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 3 3 15 4 4
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 2 participants 1 participants 11 participants 1 participants 2 participants
54.2  (5.89) 52.8  (0) 62.6  (17.50) 66.7  (0) 61.1  (23.57)
Week 4 Number Analyzed 2 participants 1 participants 11 participants 1 participants 2 participants
66.7  (19.64) 75.0  (0) 73.5  (18.19) 75.0  (0) 63.0  (0)
Week 12 Number Analyzed 1 participants 1 participants 10 participants 1 participants 3 participants
55.6  (0) 80.6  (0) 75.6  (20.32) 75.0  (0) 71.3  (15.80)
Week 24 Number Analyzed 1 participants 0 participants 9 participants 1 participants 3 participants
52.8  (0) 77.5  (21.22) 61.1  (0) 69.4  (25.46)
Week 28 Number Analyzed 1 participants 1 participants 2 participants 1 participants 1 participants
55.6  (0) 69.4  (0) 70.8  (41.25) 83.3  (0) 88.9  (0)
Week 40 Number Analyzed 1 participants 1 participants 2 participants 1 participants 2 participants
58.3  (0) 77.8  (0) 56.9  (0) 80.6  (0) 79.2  (21.61)
Week 48 Number Analyzed 0 participants 0 participants 8 participants 0 participants 0 participants
71.5  (21.45)
Week 72 Number Analyzed 1 participants 1 participants 10 participants 1 participants 1 participants
47.2  (0) 66.7  (0) 62.2  (25.43) 88.9  (0) 91.7  (0)
Week 104 Number Analyzed 0 participants 1 participants 7 participants 1 participants 2 participants
58.3  (0) 77.7  (13.12) 91.7  (0) 72.2  (27.50)
22.Secondary Outcome
Title Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Hide Description The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Time Frame Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)
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Hide Analysis Population Description
Pharmacodynamic analysis set
Arm/Group Title MCS110 3 mg/kg (PART BC) MCS110 5 mg/kg (PART BC) MCS110 10 mg/kg (Part BC) MCS110 3 mg/kg & MCS110 10mg/kg (PART BC) MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Hide Arm/Group Description:
Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 3 3 15 4 4
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 2 participants 1 participants 10 participants 1 participants 2 participants
35.0  (7.07) 25.0  (0) 29.5  (23.15) 70.0  (0) 52.5  (31.82)
Week 4 Number Analyzed 2 participants 1 participants 11 participants 1 participants 3 participants
50.0  (21.21) 70.0  (0) 40.9  (0) 100.0  (0) 48.3  (45.37)
Week 12 Number Analyzed 1 participants 1 participants 10 participants 1 participants 3 participants
45.0  (0) 85.0  (0) 58.0  (0) 85.0  (0) 45.0  (37.75)
Week 24 Number Analyzed 1 participants 0 participants 9 participants 1 participants 3 participants
30.0  (0) 55.6  (30.66) 50.0  (0) 53.3  (37.53)
Week 28 Number Analyzed 1 participants 1 participants 2 participants 1 participants 1 participants
35.0  (0) 35.0  (0) 50.0  (70.71) 95.0  (0) 95.0  (0)
Week 40 Number Analyzed 1 participants 1 participants 2 participants 1 participants 2 participants
35.0  (0) 50.0  (0) 37.5  (53.03) 90.0  (0) 80.0  (21.21)
Week 48 Number Analyzed 0 participants 0 participants 8 participants 0 participants 0 participants
48.1  (39.27)
Week 72 Number Analyzed 1 participants 1 participants 10 participants 1 participants 1 participants
30.0  (0) 40.0  (0) 40.6  (36.27) 70.0  (0) 95.0  (0)
Week 104 Number Analyzed 0 participants 1 participants 7 participants 1 participants 2 participants
30.0  (0) 58.2  (21.54) 95.0  (0) 70.0  (35.36)
23.Secondary Outcome
Title Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Hide Description The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Time Frame Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)
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Hide Analysis Population Description
Pharmacodynamic analysis set
Arm/Group Title MCS110 3 mg/kg (PART BC) MCS110 5 mg/kg (PART BC) MCS110 10 mg/kg (Part BC) MCS110 3 mg/kg & MCS110 10mg/kg (PART BC) MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Hide Arm/Group Description:
Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 3 3 15 4 4
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 2 participants 1 participants 10 participants 1 participants 2 participants
41.1  (12.63) 50.0  (0) 50.0  (16.44) 50.0  (0) 62.5  (27.78)
Week 4 Number Analyzed 2 participants 1 participants 11 participants 1 participants 3 participants
58.9  (32.83) 75.0  (0) 59.4  (16.92) 57.1  (0) 57.1  (24.74)
Week 12 Number Analyzed 1 participants 1 participants 10 participants 1 participants 3 participants
71.4  (0) 78.6  (0) 69.3  (21.31) 64.3  (0) 56.0  (26.33)
Week 24 Number Analyzed 1 participants 0 participants 9 participants 1 participants 3 participants
50.0  (0) 65.9  (25.45) 67.9  (0) 67.9  (0)
Week 28 Number Analyzed 1 participants 1 participants 2 participants 1 participants 1 participants
60.7  (0) 60.7  (0) 62.5  (53.03) 75.0  (0) 89.3  (0)
Week 40 Number Analyzed 1 participants 1 participants 2 participants 1 participants 2 participants
75.0  (0) 64.3  (0) 42.9  (60.61) 78.6  (0) 73.2  (37.88)
Week 48 Number Analyzed 0 participants 0 participants 8 participants 0 participants 0 participants
62.1  (24.29)
Week 72 Number Analyzed 1 participants 1 participants 10 participants 1 participants 1 participants
50.0  (0) 57.1  (0) 40.6  (28.43) 78.6  (0) 85.7  (0)
Week 104 Number Analyzed 0 participants 1 participants 7 participants 1 participants 2 participants
53.6  (0) 67.3  (20.63) 85.7  (0) 62.5  (32.83)
24.Secondary Outcome
Title Change From Baseline Per Treatment Using EuroQol-5 Dimensional (EQ-5D VAS)Visual Analog Scale Quality of Life Questionnaire
Hide Description The EQ-5D is a standardized measure of health status. The EQ visual analogue scale (EQ VAS)has a range from 0-100: worst possible to perfect health. Data show the absolute change from baseline of EQ5D VAS and at the different visits for participants, who received multiple doses of MCS110. (PART B and PART C).
Time Frame Week 4, Week 24, up to 104 weeks
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Hide Analysis Population Description
Pharmacodynamic analysis set
Arm/Group Title MCS110 3 mg/kg (PART BC) MCS110 5 mg/kg (PART BC) MCS110 10 mg/kg (Part BC) MCS110 3 mg/kg & MCS110 10mg/kg (PART BC) MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Hide Arm/Group Description:
Participants received multiple monthly doses of MCS110 3 mg/kg
Participants received multiple monthly doses of MCS110 5 mg/kg
Participants received multiple monthly doses of MCS110 10 mg/kg
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Overall Number of Participants Analyzed 3 3 15 4 4
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 4 Number Analyzed 2 participants 3 participants 15 participants 4 participants 4 participants
11.0  (1.41) 3.7  (5.03) 0.6  (25.07) 1.3  (2.50) 5.5  (10.85)
Week 24 Number Analyzed 1 participants 1 participants 12 participants 3 participants 4 participants
-1.0  (0.00) 10.0  (0.00) 9.5  (14.04) 1.0  (8.54) 9.8  (16.21)
Up to Week 104 Number Analyzed 0 participants 3 participants 11 participants 4 participants 3 participants
1.3  (5.51) 6.9  (13.93) 7.0  (8.91) 18.0  (25.63)
Time Frame Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MCS110 10 mg/kg (PART A) Placebo (PART A) MCS110 10mg/kg (PART B) Placebo/10mg/kg (PART B) MCS110 3mg/kg (PART C) MCS110 5mg/kg (PART C) MCS110 10mg/kg (PART C)
Hide Arm/Group Description Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg MCS110 10 mg/kg (i.v. infusion) Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again MCS110 3 mg/kg (i.v. infusion) MCS110 5 mg/kg (i.v. infusion) MCS110 10 mg/kg (i.v. infusion)
All-Cause Mortality
MCS110 10 mg/kg (PART A) Placebo (PART A) MCS110 10mg/kg (PART B) Placebo/10mg/kg (PART B) MCS110 3mg/kg (PART C) MCS110 5mg/kg (PART C) MCS110 10mg/kg (PART C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/2 (0.00%)   0/11 (0.00%)   0/3 (0.00%)   0/7 (0.00%)   0/7 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
MCS110 10 mg/kg (PART A) Placebo (PART A) MCS110 10mg/kg (PART B) Placebo/10mg/kg (PART B) MCS110 3mg/kg (PART C) MCS110 5mg/kg (PART C) MCS110 10mg/kg (PART C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   1/2 (50.00%)   2/11 (18.18%)   0/3 (0.00%)   3/7 (42.86%)   1/7 (14.29%)   4/12 (33.33%) 
Gastrointestinal disorders               
Nausea  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Oesophageal spasm  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Vomiting  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
General disorders               
Gait disturbance  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Non-cardiac chest pain  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Pain  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Pyrexia  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Hepatobiliary disorders               
Cholecystitis acute  1  0/5 (0.00%)  1/2 (50.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Infections and infestations               
Laryngitis  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Meningoencephalitis viral  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Streptococcal bacteraemia  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Viral infection  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications               
Infusion related reaction  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  0/7 (0.00%)  0/12 (0.00%) 
Investigations               
Alanine aminotransferase increased  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Aspartate aminotransferase increased  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Blood creatine phosphokinase increased  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Electrocardiogram ST segment depression  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Haemoglobin decreased  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Metabolism and nutrition disorders               
Dehydration  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Nervous system disorders               
Dizziness  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Dysarthria  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Facial paralysis  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Product Issues               
Device dislocation  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Dyspnoea  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Nasal congestion  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MCS110 10 mg/kg (PART A) Placebo (PART A) MCS110 10mg/kg (PART B) Placebo/10mg/kg (PART B) MCS110 3mg/kg (PART C) MCS110 5mg/kg (PART C) MCS110 10mg/kg (PART C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/5 (60.00%)   1/2 (50.00%)   11/11 (100.00%)   3/3 (100.00%)   7/7 (100.00%)   6/7 (85.71%)   11/12 (91.67%) 
Blood and lymphatic system disorders               
Iron deficiency anaemia  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  1/12 (8.33%) 
Leukopenia  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Lymphadenopathy  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Neutropenia  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Cardiac disorders               
Pericardial effusion  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Ear and labyrinth disorders               
Ear pain  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Endocrine disorders               
Autoimmune thyroiditis  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Eye disorders               
Blepharitis  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Dark circles under eyes  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Eye pruritus  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Eye swelling  1  0/5 (0.00%)  0/2 (0.00%)  3/11 (27.27%)  0/3 (0.00%)  1/7 (14.29%)  1/7 (14.29%)  0/12 (0.00%) 
Eyelid oedema  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Papilloedema  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Periorbital oedema  1  0/5 (0.00%)  0/2 (0.00%)  4/11 (36.36%)  0/3 (0.00%)  5/7 (71.43%)  3/7 (42.86%)  4/12 (33.33%) 
Periorbital swelling  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  1/12 (8.33%) 
Gastrointestinal disorders               
Abdominal pain  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Dental caries  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Diarrhoea  1  0/5 (0.00%)  0/2 (0.00%)  4/11 (36.36%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Haematochezia  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Haemorrhoidal haemorrhage  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Nausea  1  0/5 (0.00%)  1/2 (50.00%)  5/11 (45.45%)  0/3 (0.00%)  1/7 (14.29%)  3/7 (42.86%)  1/12 (8.33%) 
Stomatitis  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Vomiting  1  0/5 (0.00%)  0/2 (0.00%)  3/11 (27.27%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
General disorders               
Administration site rash  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Chills  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Face oedema  1  1/5 (20.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Fatigue  1  0/5 (0.00%)  0/2 (0.00%)  4/11 (36.36%)  0/3 (0.00%)  5/7 (71.43%)  2/7 (28.57%)  2/12 (16.67%) 
Infusion site pain  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Non-cardiac chest pain  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Oedema peripheral  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  1/3 (33.33%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Pain  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Peripheral swelling  1  0/5 (0.00%)  0/2 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  2/7 (28.57%)  3/7 (42.86%)  3/12 (25.00%) 
Pyrexia  1  0/5 (0.00%)  0/2 (0.00%)  3/11 (27.27%)  0/3 (0.00%)  2/7 (28.57%)  0/7 (0.00%)  0/12 (0.00%) 
Soft tissue inflammation  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Swelling  1  0/5 (0.00%)  0/2 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Immune system disorders               
Drug hypersensitivity  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Seasonal allergy  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Infections and infestations               
Cellulitis  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Conjunctivitis  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Gastroenteritis  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Gastroenteritis norovirus  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Herpes zoster  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Influenza  1  1/5 (20.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Nasopharyngitis  1  0/5 (0.00%)  0/2 (0.00%)  4/11 (36.36%)  0/3 (0.00%)  1/7 (14.29%)  2/7 (28.57%)  3/12 (25.00%) 
Peritonsillitis  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Sinusitis  1  1/5 (20.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Subcutaneous abscess  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Tonsillitis  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Upper respiratory tract infection  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  1/3 (33.33%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Urinary tract infection  1  0/5 (0.00%)  0/2 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Viral infection  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications               
Contusion  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Fall  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Fibula fracture  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Foot fracture  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Infusion related reaction  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  1/7 (14.29%)  2/12 (16.67%) 
Procedural dizziness  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Investigations               
Alanine aminotransferase increased  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Amylase increased  1  1/5 (20.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/12 (16.67%) 
Antinuclear antibody positive  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Aspartate aminotransferase increased  1  1/5 (20.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/12 (16.67%) 
Blood cholesterol increased  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Blood creatine phosphokinase increased  1  1/5 (20.00%)  1/2 (50.00%)  4/11 (36.36%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/12 (16.67%) 
Blood lactate dehydrogenase increased  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Blood pressure increased  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Blood triglycerides increased  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Gamma-glutamyltransferase increased  1  1/5 (20.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Haemoglobin decreased  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Lipase increased  1  1/5 (20.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/12 (16.67%) 
Metabolism and nutrition disorders               
Decreased appetite  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Dehydration  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Fluid retention  1  0/5 (0.00%)  0/2 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  1/3 (33.33%)  2/7 (28.57%)  2/7 (28.57%)  2/12 (16.67%) 
Arthritis  1  1/5 (20.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Joint stiffness  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Joint swelling  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  1/3 (33.33%)  1/7 (14.29%)  0/7 (0.00%)  3/12 (25.00%) 
Muscle spasms  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Myalgia  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Neck pain  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Pain in extremity  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  2/7 (28.57%)  0/12 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Benign joint neoplasm  1  1/5 (20.00%)  0/2 (0.00%)  4/11 (36.36%)  0/3 (0.00%)  0/7 (0.00%)  3/7 (42.86%)  2/12 (16.67%) 
Nervous system disorders               
Dizziness  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Headache  1  2/5 (40.00%)  0/2 (0.00%)  4/11 (36.36%)  0/3 (0.00%)  2/7 (28.57%)  2/7 (28.57%)  2/12 (16.67%) 
Hypoaesthesia  1  1/5 (20.00%)  0/2 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Intracranial pressure increased  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Migraine  1  0/5 (0.00%)  0/2 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  1/12 (8.33%) 
Paraesthesia  1  0/5 (0.00%)  0/2 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Sciatica  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Psychiatric disorders               
Anxiety  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Depression  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Mental status changes  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Reproductive system and breast disorders               
Menstrual disorder  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Bronchospasm  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Cough  1  0/5 (0.00%)  0/2 (0.00%)  3/11 (27.27%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  1/12 (8.33%) 
Epistaxis  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Oropharyngeal pain  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders               
Acne  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Alopecia  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Dermal cyst  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/12 (0.00%) 
Dermatitis acneiform  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Eczema  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Erythema nodosum  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Hyperhidrosis  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Pruritus  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Pruritus generalised  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Psoriasis  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Rash  1  0/5 (0.00%)  0/2 (0.00%)  4/11 (36.36%)  0/3 (0.00%)  2/7 (28.57%)  2/7 (28.57%)  2/12 (16.67%) 
Rash generalised  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Skin wrinkling  1  0/5 (0.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Swelling face  1  0/5 (0.00%)  0/2 (0.00%)  3/11 (27.27%)  0/3 (0.00%)  1/7 (14.29%)  1/7 (14.29%)  1/12 (8.33%) 
Vascular disorders               
Hot flush  1  0/5 (0.00%)  0/2 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Hypertension  1  0/5 (0.00%)  0/2 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Hypotension  1  1/5 (20.00%)  0/2 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01643850    
Other Study ID Numbers: CMCS110X2201
2011-002951-32 ( EudraCT Number )
First Submitted: March 8, 2012
First Posted: July 18, 2012
Results First Submitted: June 20, 2019
Results First Posted: February 27, 2020
Last Update Posted: January 5, 2021