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A Study With Tasquinimod Treating Patients With Hepatocellular, Ovarian, Renal Cell and Gastric Cancers

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ClinicalTrials.gov Identifier: NCT01743469
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : May 7, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced or Metastatic Hepatocellular Cancer
Advanced or Metastatic Ovarian Cancer
Metastatic Renal Cell Cancer
Advanced or Metastatic Gastric Carcinoma
Intervention Drug: Tasquinimod
Enrollment 201
Recruitment Details Patients were recruited from 24 investigational sites in Belgium, Canada, the United Kingdom, Spain and France. The first patient was enrolled in December 2012 and the study was completed in April 2016.
Pre-assignment Details In the hepatocellular carcinoma cohort 67 patients were screened, of whom 53 were treated with tasquinimod. In the ovarian carcinoma cohort 63 were screened, of whom 55 were treated. In the renal cell carcinoma cohort 44 were screened, of whom 38 were treated. In the gastric carcinoma cohort 27 were screened, of whom 21 were treated.
Arm/Group Title Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Hide Arm/Group Description

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Period Title: Active Treatment Phase
Started 53 55 38 21
Completed 0 0 0 0
Not Completed 53 55 38 21
Reason Not Completed
Adverse Event             10             5             8             1
Disease Progression             40             47             30             20
Withdrawal by Subject             2             3             0             0
Missing             1             0             0             0
Period Title: Follow-up Period - Post-Treatment
Started [1] 51 53 37 21
Completed 6 5 14 5
Not Completed 45 48 23 16
Reason Not Completed
Withdrawal by Subject             1             0             1             0
Death             43             47             22             16
Lost to Follow-up             1             1             0             0
[1]
Entered into follow-up after last treatment with study drug
Arm/Group Title Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort Total
Hide Arm/Group Description

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 53 55 38 21 167
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population: All treated patients i.e. all patients who had received at least one dose of tasquinimod.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 38 participants 21 participants 167 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  35.8%
34
  61.8%
25
  65.8%
11
  52.4%
89
  53.3%
>=65 years
34
  64.2%
21
  38.2%
13
  34.2%
10
  47.6%
78
  46.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 38 participants 21 participants 167 participants
Female
8
  15.1%
55
 100.0%
10
  26.3%
4
  19.0%
77
  46.1%
Male
45
  84.9%
0
   0.0%
28
  73.7%
17
  81.0%
90
  53.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 38 participants 21 participants 167 participants
Hispanic or Latino
1
   1.9%
0
   0.0%
1
   2.6%
0
   0.0%
2
   1.2%
Not Hispanic or Latino
33
  62.3%
53
  96.4%
33
  86.8%
19
  90.5%
138
  82.6%
Unknown or Not Reported
19
  35.8%
2
   3.6%
4
  10.5%
2
   9.5%
27
  16.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 38 participants 21 participants 167 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   5.7%
2
   3.6%
0
   0.0%
2
   9.5%
7
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   3.8%
2
   3.6%
0
   0.0%
0
   0.0%
4
   2.4%
White
29
  54.7%
49
  89.1%
35
  92.1%
17
  81.0%
130
  77.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
19
  35.8%
2
   3.6%
3
   7.9%
2
   9.5%
26
  15.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 38 participants 21 participants 167 participants
Canada 3 22 9 4 38
Belgium 3 10 0 2 15
United Kingdom 3 11 14 13 41
France 43 9 12 2 66
Spain 1 3 3 0 7
1.Primary Outcome
Title Progression Free Survival (PFS) Rate, Defined as the Percentage of Patients Who Had Neither Progressed Nor Died as Measured by Centrally Analysed RECIST v1.1 (All Cohorts).
Hide Description

Progression (prog.) defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in sum of longest diameter of target lesions,or a measurable increase in a nontarget lesion,or appearance of new lesions.

'Progressed or Died' when time between start of study drug &first date of the following events was ≤ to analysis timepoint +3 days:1) Disease prog. according to central review using RECIST v1.1:date of disease prog. or if missing,first exam date of the visit showing a disease prog.2) Death due to any cause.

'Neither progressed, nor died' if central assessment by RECIST v1.1 confirmed no disease prog. was observed at the considered timepoint,i.e. time between start of study medication &last examination/visit date of complete response (CR),partial response (PR) or stable disease (SD) ≥ analysis timepoint 7days.In other cases, such as patient withdrawal due to AEs without tumor assessment proving prog.,the patient was considered as 'not assessable'.

Time Frame Week 12 (Gastric Carcinoma Cohort); Week 16 (Hepatocellular and Renal Cell Carcinoma Cohorts); Week 24 (Ovarian Carcinoma Cohort).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All treated patients i.e. all patients who had received at least one dose of tasquinimod. An additional patient was included in the hepatocellular carcinoma cohort, since the 52nd (last patient planned in the protocol) and 53rd were screened at the same time. This 53rd was not included in the primary analysis.
Arm/Group Title Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 52 55 38 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.9
(15.57 to 41.02)
7.3
(2.02 to 17.59)
13.2
(4.41 to 28.09)
9.5
(1.17 to 30.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hepatocellular Carcinoma Cohort
Comments The PFS rate was compared with the prespecified threshold (>20%).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments One-sided alpha of 0.1.
Method Exact binomial test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ovarian Carcinoma Cohort
Comments The PFS rate was compared with the prespecified threshold (>35%).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments One-sided alpha of 0.1.
Method Exact binomial test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Renal Cell Carcinoma Cohort
Comments The PFS rate was compared with the prespecified threshold (>20%).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.800
Comments One-sided alpha of 0.1
Method Exact binomial test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Gastric Carcinoma Cohort
Comments The PFS rate was compared with the prespecified threshold (>15%).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.630
Comments One-sided alpha of 0.1
Method Exact binomial test
Comments [Not Specified]
2.Secondary Outcome
Title PFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort).
Hide Description

PFS rate was defined as the percentage of patients who had neither progressed nor died. Tumour progression was assessed centrally using the Choi criteria.

Response was measured using the following criteria:

CR: Disappearance of all lesions, no new lesions; PR: A decrease in size ≥10% or a decrease in tumour attenuation (Hounsfield unit [HU]) ≥15% on CT, no new lesions, no obvious progression of non-measurable disease; SD: Does not meet criteria for CR, PR, or progressive disease (PD), no symptomatic deterioration attributed to tumour progression; PD: An increase in tumour size ≥10% and does not meet criteria of PR by tumour attenuation on CT, new lesions.

Time Frame Week 16.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Arm/Group Title Hepatocellular Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.8
(10.84 to 34.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hepatocellular Carcinoma Cohort
Comments The PFS rate was compared with a prespecified threshold (>20%).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments One-sided alpha of 0.1.
Method Exact binomial test
Comments [Not Specified]
3.Secondary Outcome
Title Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Hide Description Best overall response was derived as the best overall response documented before the prespecified timepoint (gastric carcinoma cohort: 12 weeks; Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Time Frame Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all treated patients i.e. all patients who had received at lease one dose of tasquinimod.
Arm/Group Title Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 53 55 38 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Best overall response: PR (centrally assessed)
1.9
(0.05 to 10.07)
1.8
(0.05 to 9.72)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Best overall response: SD (centrally assessed)
54.7
(40.45 to 68.44)
49.1
(35.35 to 62.93)
47.4
(30.98 to 64.18)
23.8
(8.22 to 47.17)
Best overall response: PD (centrally assessed)
34.0
(21.52 to 48.27)
41.8
(28.65 to 55.89)
44.7
(28.62 to 61.70)
66.7
(43.03 to 85.41)
Best overall response: NE (centrally assessed)
9.4
(3.13 to 20.66)
7.3
(2.02 to 17.59)
7.9
(1.66 to 21.38)
9.5
(1.17 to 30.38)
Response rate (CR or PR) (centrally assessed)
1.9
(0.05 to 10.07)
1.8
(0.05 to 9.72)
0 [2] 
(NA to NA)
0 [2] 
(NA to NA)
Best overall response: PR (locally assessed)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Best overall response: SD (locally assessed)
52.8
(38.64 to 66.70)
32.7
(20.68 to 46.71)
39.5
(24.04 to 56.61)
14.3
(3.05 to 36.34)
Best overall response: PD (locally assessed)
43.4
(29.84 to 57.72)
61.8
(47.73 to 74.59)
57.9
(40.82 to 73.69)
81.0
(58.09 to 94.55)
Best overall response: NE (locally assessed)
3.8
(0.46 to 12.98)
5.5
(1.14 to 15.12)
2.6
(0.07 to 13.81)
4.8
(0.12 to 23.82)
Response rate (CR or PR) (locally assessed)
0 [2] 
(NA to NA)
0 [2] 
(NA to NA)
0 [2] 
(NA to NA)
0 [2] 
(NA to NA)
[1]
No patients had PR as best overall response, unable to compute 95% CI.
[2]
No patients had CR or PR as best overall response, unable to compute 95% CI.
4.Secondary Outcome
Title Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).
Hide Description Per Choi Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=10% decrease in the sum of the longest diameter of target lesions; Progression, as a 10% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Time Frame Every 8 weeks until disease progression, up to 36 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Arm/Group Title Hepatocellular Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Best overall response: PR
20.8
(10.84 to 34.11)
Best overall response: SD
32.1
(19.92 to 46.32)
Best overall response: PD
34.0
(21.52 to 48.27)
Best overall response: NE
13.2
(5.48 to 25.34)
Response rate (CR or PR)
20.8
(10.84 to 34.11)
5.Secondary Outcome
Title Clinical Benefit (All Cohorts).
Hide Description Clinical benefit was defined as CR, PR or SD lasting at least 12 weeks using centrally or locally assessed RECIST v1.1.
Time Frame Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Arm/Group Title Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 53 55 38 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Clinical benefit (centrally assessed)
26.4
(15.26 to 40.33)
20.0
(10.43 to 32.97)
15.8
(6.02 to 31.25)
0.0 [1] 
(NA to NA)
Clinical benefit (locally assessed)
32.1
(19.92 to 46.32)
16.4
(7.77 to 28.80)
15.8
(6.02 to 31.25)
0.0 [1] 
(NA to NA)
[1]
No patients derived clinical benefit, unable to compute 95% CI.
6.Secondary Outcome
Title PFS From First Study Treatment to Progression or Death Due to Any Cause Based on Choi Criteria (Hepatocellular Carcinoma Cohort).
Hide Description PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to any cause before initiation of new systemic treatment.
Time Frame Every 8 weeks until disease progression, up to 36 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Arm/Group Title Hepatocellular Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 53
Median (95% Confidence Interval)
Unit of Measure: Weeks
15.71
(8.00 to 16.43)
7.Secondary Outcome
Title PFS From First Study Treatment to Progression or Death Due to Any Cause Based on RECIST v1.1 Criteria (All Cohorts).
Hide Description PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally and locally assessed RECIST v1.1 (i.e. increase in tumor size ≥20%) or death due to any cause before initiation of new systemic treatment.
Time Frame Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Arm/Group Title Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 53 55 38 21
Median (95% Confidence Interval)
Unit of Measure: Weeks
PFS (centrally assessed)
15.86
(8.00 to 23.14)
8.00
(7.71 to 17.43)
14.86
(7.86 to 16.71)
6.00
(5.29 to 7.29)
PFS (locally assessed)
15.71
(8.00 to 16.43)
7.57
(7.00 to 7.86)
7.86
(7.29 to 14.71)
5.79
(5.14 to 6.86)
8.Secondary Outcome
Title Time to Progression (TTP) by Choi Criteria (Hepatocellular Carcinoma Cohort).
Hide Description TTP defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to disease progression before initiation of a new systemic treatment.
Time Frame Every 8 weeks until disease progression, up to 36 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Arm/Group Title Hepatocellular Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 53
Median (95% Confidence Interval)
Unit of Measure: Weeks
15.86
(8.43 to 16.43)
9.Secondary Outcome
Title TTP by RECIST v1.1 (All Cohorts).
Hide Description TTP was defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally and locally assessed RECIST v1.1 criteria (i.e. increase in tumor size ≥20%) or death due to disease progression before initiation of a new systemic treatment.
Time Frame Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Arm/Group Title Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 53 55 38 21
Median (95% Confidence Interval)
Unit of Measure: Weeks
TTP (centrally assessed)
15.86
(8.43 to 24.00)
8.00
(7.71 to 17.43)
14.86
(7.86 to 16.00)
6.00
(5.29 to 7.29)
TTP (locally assessed)
15.71
(8.00 to 16.43)
7.57
(7.00 to 7.86)
7.86
(7.29 to 14.71)
5.79
(5.14 to 6.86)
10.Secondary Outcome
Title Overall Survival (OS), Defined as the Time From First Study Treatment to Death Due to Any Cause (All Cohorts).
Hide Description

OS is the time (in weeks) from the first study medication date to death due to any cause. Patients were censored at the date of last contact (the latest between the time of EoST/WD assessment and follow-up visits).

OS was estimated using Kaplan-Meier analysis.

Time Frame Time from first study treatment to death, up to 36 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Arm/Group Title Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 53 55 38 21
Median (95% Confidence Interval)
Unit of Measure: Weeks
29.29
(25.00 to 38.71)
NA [1] 
(30.71 to NA)
32.71
(26.43 to 40.86)
21.57
(13.86 to 33.29)
[1]
Median could not be calculated as there was insufficient number of participants with events.
11.Secondary Outcome
Title Further Cancer-related Treatment During Follow-up Period (All Cohorts).
Hide Description

Further systemic treatment was coded using World Health Organization (WHO) Drug Dictionary (versions: June 2014 for the hepatocellular carcinoma cohort and June 2013 for the ovarian, renal cell and gastric carcinoma cohorts).

A frequency table of the number and percentage of patients was provided by Anatomical Therapeutic Chemical (ATC) decode and preferred name.

Time Frame 16 weeks, Last Patient First Treatment + 16 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Arm/Group Title Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Hide Arm/Group Description:

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

Overall Number of Participants Analyzed 53 55 38 21
Measure Type: Count of Participants
Unit of Measure: Participants
16
  30.2%
35
  63.6%
18
  47.4%
8
  38.1%
Time Frame Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Adverse Event Reporting Description

Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation.

The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.

 
Arm/Group Title Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Hide Arm/Group Description

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

All-Cause Mortality
Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   38/53 (71.70%)      22/55 (40.00%)      22/38 (57.89%)      16/21 (76.19%)    
Show Serious Adverse Events Hide Serious Adverse Events
Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/53 (26.42%)      19/55 (34.55%)      11/38 (28.95%)      7/21 (33.33%)    
Blood and lymphatic system disorders         
Anaemia  1  2/53 (3.77%)  2 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Cardiac disorders         
Myocardial infarction  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Cardiac failure  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Gastrointestinal disorders         
Nausea  1  0/53 (0.00%)  0 0/55 (0.00%)  0 0/38 (0.00%)  0 2/21 (9.52%)  2
Vomiting  1  1/53 (1.89%)  1 1/55 (1.82%)  1 0/38 (0.00%)  0 2/21 (9.52%)  2
Small intestinal obstruction  1  0/53 (0.00%)  0 2/55 (3.64%)  2 0/38 (0.00%)  0 0/21 (0.00%)  0
Lower gastrointestinal haemorrhage  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Oesophageal varices haemorrhage  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Pancreatitis  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Abdominal pain  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Abdominal pain upper  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Diarrhoea  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Intestinal obstruction  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Ascites  1  1/53 (1.89%)  1 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Subileus  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Rectal haemorrhage  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Colitis  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
General disorders         
Asthenia  1  2/53 (3.77%)  2 0/55 (0.00%)  0 0/38 (0.00%)  0 1/21 (4.76%)  1
Oedema peripheral  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 1/21 (4.76%)  1
Fatigue  1  1/53 (1.89%)  1 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Non-cardiac chest pain  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Pyrexia  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Disease progression  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Hepatobiliary disorders         
Bile duct obstruction  1  0/53 (0.00%)  0 0/55 (0.00%)  0 0/38 (0.00%)  0 1/21 (4.76%)  1
Hepatobiliary disease  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Infections and infestations         
Cellulitis  1  0/53 (0.00%)  0 0/55 (0.00%)  0 0/38 (0.00%)  0 1/21 (4.76%)  1
Upper respiratory tract infection  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Peritonitis  1  2/53 (3.77%)  2 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Infectious pleural effusion  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Lung infection  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Pelvic infection  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Pleural infection  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Urinary tract infection  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Lower respiratory tract infection  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Pneumonia  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Oesophageal candidiasis  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Oral candidiasis  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Injury, poisoning and procedural complications         
Humerus fracture  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Upper limb fracture  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Investigations         
Blood bilirubin increased  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Blood creatinine increased  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 1/21 (4.76%)  1
Decreased appetite  1  2/53 (3.77%)  2 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Hypercalcaemia  1  0/53 (0.00%)  0 1/55 (1.82%)  2 0/38 (0.00%)  0 0/21 (0.00%)  0
Hyperkalaemia  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Iron deficiency  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Flank pain  1  0/53 (0.00%)  0 0/55 (0.00%)  0 0/38 (0.00%)  0 1/21 (4.76%)  1
Back pain  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Pathological fracture  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Pain in extremity  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Inflammatory myofibroblastic tumour  1  0/53 (0.00%)  0 0/55 (0.00%)  0 0/38 (0.00%)  0 1/21 (4.76%)  1
Tumour pain  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Metastatic pain  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Nervous system disorders         
Hepatic encephalopathy  1  1/53 (1.89%)  1 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Ataxia  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Dizziness  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Partial seizures  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Renal and urinary disorders         
Renal failure acute  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 1/21 (4.76%)  1
Renal failure  1  1/53 (1.89%)  1 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pleural effusion  1  0/53 (0.00%)  0 4/55 (7.27%)  4 0/38 (0.00%)  0 0/21 (0.00%)  0
Cough  1  0/53 (0.00%)  0 1/55 (1.82%)  2 0/38 (0.00%)  0 0/21 (0.00%)  0
Dyspnoea  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Pulmonary embolism  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 0/21 (0.00%)  0
Haemoptysis  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Pleuritic pain  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
1
Term from vocabulary, MedDRA 16.1/17.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hepatocellular Carcinoma Cohort Ovarian Carcinoma Cohort Renal Cell Carcinoma Cohort Gastric Carcinoma Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/53 (100.00%)      55/55 (100.00%)      38/38 (100.00%)      21/21 (100.00%)    
Blood and lymphatic system disorders         
Anaemia  1  2/53 (3.77%)  2 9/55 (16.36%)  9 3/38 (7.89%)  3 5/21 (23.81%)  7
Cardiac disorders         
Sinus tachycardia  1  0/53 (0.00%)  0 3/55 (5.45%)  3 0/38 (0.00%)  0 1/21 (4.76%)  1
Eye disorders         
Periorbital oedema  1  0/53 (0.00%)  0 4/55 (7.27%)  4 0/38 (0.00%)  0 0/21 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  15/53 (28.30%)  17 19/55 (34.55%)  20 8/38 (21.05%)  8 9/21 (42.86%)  11
Nausea  1  21/53 (39.62%)  28 24/55 (43.64%)  30 12/38 (31.58%)  13 13/21 (61.90%)  17
Vomiting  1  18/53 (33.96%)  25 16/55 (29.09%)  21 9/38 (23.68%)  9 13/21 (61.90%)  18
Constipation  1  15/53 (28.30%)  16 12/55 (21.82%)  12 13/38 (34.21%)  13 11/21 (52.38%)  13
Gastrooesophageal reflux disease  1  0/53 (0.00%)  0 1/55 (1.82%)  1 1/38 (2.63%)  2 5/21 (23.81%)  6
Dyspepsia  1  0/53 (0.00%)  0 5/55 (9.09%)  6 2/38 (5.26%)  2 4/21 (19.05%)  4
Diarrhoea  1  14/53 (26.42%)  20 14/55 (25.45%)  18 7/38 (18.42%)  8 3/21 (14.29%)  3
Abdominal distension  1  4/53 (7.55%)  4 10/55 (18.18%)  12 1/38 (2.63%)  1 2/21 (9.52%)  2
Abdominal pain upper  1  7/53 (13.21%)  9 13/55 (23.64%)  14 1/38 (2.63%)  1 2/21 (9.52%)  2
Epigastric discomfort  1  0/53 (0.00%)  0 0/55 (0.00%)  0 0/38 (0.00%)  0 2/21 (9.52%)  2
Eructation  1  0/53 (0.00%)  0 1/55 (1.82%)  1 0/38 (0.00%)  0 2/21 (9.52%)  2
Retching  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 2/21 (9.52%)  4
Ascites  1  5/53 (9.43%)  8 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Dysphagia  1  3/53 (5.66%)  4 1/55 (1.82%)  1 1/38 (2.63%)  2 1/21 (4.76%)  1
Dry mouth  1  2/53 (3.77%)  2 3/55 (5.45%)  3 0/38 (0.00%)  0 1/21 (4.76%)  1
General disorders         
Oedema peripheral  1  16/53 (30.19%)  18 17/55 (30.91%)  21 4/38 (10.53%)  9 2/21 (9.52%)  2
Fatigue  1  31/53 (58.49%)  36 31/55 (56.36%)  41 7/38 (18.42%)  7 15/21 (71.43%)  18
Asthenia  1  7/53 (13.21%)  8 5/55 (9.09%)  7 11/38 (28.95%)  17 0/21 (0.00%)  0
Pyrexia  1  2/53 (3.77%)  4 8/55 (14.55%)  10 1/38 (2.63%)  1 1/21 (4.76%)  1
Chest pain  1  1/53 (1.89%)  1 0/55 (0.00%)  0 2/38 (5.26%)  2 0/21 (0.00%)  0
Chills  1  0/53 (0.00%)  0 2/55 (3.64%)  2 2/38 (5.26%)  2 1/21 (4.76%)  1
Influenza like illness  1  0/53 (0.00%)  0 0/55 (0.00%)  0 2/38 (5.26%)  2 0/21 (0.00%)  0
Infections and infestations         
Lower respiratory tract infection  1  0/53 (0.00%)  0 0/55 (0.00%)  0 5/38 (13.16%)  6 3/21 (14.29%)  3
Oral candidiasis  1  1/53 (1.89%)  1 2/55 (3.64%)  2 0/38 (0.00%)  0 3/21 (14.29%)  4
Urinary tract infection  1  1/53 (1.89%)  1 7/55 (12.73%)  7 0/38 (0.00%)  0 2/21 (9.52%)  3
Rash pustular  1  4/53 (7.55%)  4 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Bronchitis  1  3/53 (5.66%)  3 0/55 (0.00%)  0 1/38 (2.63%)  1 0/21 (0.00%)  0
Injury, poisoning and procedural complications         
Fall  1  0/53 (0.00%)  0 4/55 (7.27%)  5 0/38 (0.00%)  0 3/21 (14.29%)  4
Investigations         
Weight decreased  1  13/53 (24.53%)  14 3/55 (5.45%)  3 5/38 (13.16%)  5 6/21 (28.57%)  6
Blood alkaline phosphatase increased  1  1/53 (1.89%)  1 4/55 (7.27%)  4 1/38 (2.63%)  1 3/21 (14.29%)  3
Alanine aminotransferase increased  1  3/53 (5.66%)  3 6/55 (10.91%)  7 0/38 (0.00%)  0 2/21 (9.52%)  3
Aspartate aminotransferase increased  1  4/53 (7.55%)  4 6/55 (10.91%)  7 1/38 (2.63%)  1 2/21 (9.52%)  2
Blood lactate dehydrogenase increased  1  0/53 (0.00%)  0 0/55 (0.00%)  0 0/38 (0.00%)  0 2/21 (9.52%)  2
Blood bilirubin increased  1  4/53 (7.55%)  4 2/55 (3.64%)  2 0/38 (0.00%)  0 0/21 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/53 (1.89%)  1 5/55 (9.09%)  5 1/38 (2.63%)  1 0/21 (0.00%)  0
Lipase increased  1  0/53 (0.00%)  0 6/55 (10.91%)  6 0/38 (0.00%)  0 0/21 (0.00%)  0
Amylase increased  1  0/53 (0.00%)  0 5/55 (9.09%)  5 0/38 (0.00%)  0 0/21 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  21/53 (39.62%)  22 20/55 (36.36%)  25 11/38 (28.95%)  11 15/21 (71.43%)  17
Hyponatraemia  1  1/53 (1.89%)  2 3/55 (5.45%)  3 0/38 (0.00%)  0 0/21 (0.00%)  0
Hypercalcaemia  1  0/53 (0.00%)  0 3/55 (5.45%)  3 0/38 (0.00%)  0 0/21 (0.00%)  0
Hypokalaemia  1  1/53 (1.89%)  1 3/55 (5.45%)  3 0/38 (0.00%)  0 0/21 (0.00%)  0
Hypoalbuminaemia  1  2/53 (3.77%)  3 6/55 (10.91%)  6 0/38 (0.00%)  0 0/21 (0.00%)  0
Hyperglycaemia  1  0/53 (0.00%)  0 4/55 (7.27%)  5 0/38 (0.00%)  0 0/21 (0.00%)  0
Hypomagnesaemia  1  0/53 (0.00%)  0 4/55 (7.27%)  4 0/38 (0.00%)  0 1/21 (4.76%)  1
Glucose tolerance impaired  1  0/53 (0.00%)  0 3/55 (5.45%)  3 0/38 (0.00%)  0 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  9/53 (16.98%)  11 14/55 (25.45%)  15 5/38 (13.16%)  6 11/21 (52.38%)  12
Pain in extremity  1  4/53 (7.55%)  6 5/55 (9.09%)  6 4/38 (10.53%)  6 4/21 (19.05%)  5
Flank pain  1  2/53 (3.77%)  3 2/55 (3.64%)  2 1/38 (2.63%)  1 2/21 (9.52%)  2
Arthralgia  1  5/53 (9.43%)  8 10/55 (18.18%)  11 2/38 (5.26%)  3 3/21 (14.29%)  5
Musculoskeletal pain  1  3/53 (5.66%)  4 4/55 (7.27%)  5 4/38 (10.53%)  6 2/21 (9.52%)  2
Myalgia  1  2/53 (3.77%)  3 6/55 (10.91%)  6 4/38 (10.53%)  4 2/21 (9.52%)  2
Bone pain  1  4/53 (7.55%)  4 2/55 (3.64%)  2 0/38 (0.00%)  0 0/21 (0.00%)  0
Neck pain  1  3/53 (5.66%)  3 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Muscular weakness  1  1/53 (1.89%)  1 3/55 (5.45%)  3 1/38 (2.63%)  1 0/21 (0.00%)  0
Nervous system disorders         
Headache  1  9/53 (16.98%)  9 10/55 (18.18%)  13 4/38 (10.53%)  4 1/21 (4.76%)  1
Peripheral sensory neuropathy  1  4/53 (7.55%)  4 2/55 (3.64%)  2 2/38 (5.26%)  2 1/21 (4.76%)  1
Dizziness  1  2/53 (3.77%)  2 5/55 (9.09%)  5 4/38 (10.53%)  5 1/21 (4.76%)  1
Amnesia  1  0/53 (0.00%)  0 3/55 (5.45%)  3 0/38 (0.00%)  0 0/21 (0.00%)  0
Lethargy  1  0/53 (0.00%)  0 2/55 (3.64%)  2 5/38 (13.16%)  5 1/21 (4.76%)  1
Dysgeusia  1  1/53 (1.89%)  1 1/55 (1.82%)  1 2/38 (5.26%)  2 0/21 (0.00%)  0
Neuralgia  1  0/53 (0.00%)  0 0/55 (0.00%)  0 2/38 (5.26%)  2 0/21 (0.00%)  0
Psychiatric disorders         
Insomnia  1  9/53 (16.98%)  11 9/55 (16.36%)  10 6/38 (15.79%)  6 6/21 (28.57%)  6
Reproductive system and breast disorders         
Pelvic pain  1  1/53 (1.89%)  1 3/55 (5.45%)  3 0/38 (0.00%)  0 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  5/53 (9.43%)  5 12/55 (21.82%)  12 9/38 (23.68%)  10 3/21 (14.29%)  3
Dyspnoea  1  10/53 (18.87%)  12 12/55 (21.82%)  13 3/38 (7.89%)  3 1/21 (4.76%)  1
Pleural effusion  1  1/53 (1.89%)  1 2/55 (3.64%)  2 2/38 (5.26%)  2 0/21 (0.00%)  0
Dyspnoea exertional  1  0/53 (0.00%)  0 3/55 (5.45%)  3 0/38 (0.00%)  0 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dry skin  1  3/53 (5.66%)  3 1/55 (1.82%)  1 3/38 (7.89%)  3 1/21 (4.76%)  1
Pruritus  1  2/53 (3.77%)  2 4/55 (7.27%)  4 3/38 (7.89%)  4 0/21 (0.00%)  0
Rash  1  0/53 (0.00%)  0 4/55 (7.27%)  5 3/38 (7.89%)  3 0/21 (0.00%)  0
Hyperhidrosis  1  0/53 (0.00%)  0 3/55 (5.45%)  3 3/38 (7.89%)  3 1/21 (4.76%)  1
Palmar-plantar erythrodysaesthesia syndrome  1  0/53 (0.00%)  0 2/55 (3.64%)  2 3/38 (7.89%)  3 0/21 (0.00%)  0
Night sweats  1  1/53 (1.89%)  1 2/55 (3.64%)  2 2/38 (5.26%)  2 1/21 (4.76%)  1
Vascular disorders         
Orthostatic hypotension  1  0/53 (0.00%)  0 0/55 (0.00%)  0 1/38 (2.63%)  1 2/21 (9.52%)  2
Hypertension  1  3/53 (5.66%)  4 0/55 (0.00%)  0 0/38 (0.00%)  0 0/21 (0.00%)  0
Hypotension  1  1/53 (1.89%)  1 1/55 (1.82%)  1 5/38 (13.16%)  5 1/21 (4.76%)  2
1
Term from vocabulary, MedDRA 16.1/17.1
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 Sponsor required reasonable opportunity to review any abstract, presentation, or paper before the material was submitted for publication or communicated. This also applied to any amendments that were requested by referees or journal editors. The Sponsor committed to comment on the draft documents within a time period agreed in the contractual arrangements between the Sponsor and authors or their institution. Delays were also possible if publication would adversely affect patentability.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director, Oncology
Organization: Ipsen
Phone: clinical.trials@ipsen.com
EMail: clinical.trials@ipsen.com
Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01743469     History of Changes
Other Study ID Numbers: 8-55-58102-004
2012-002326-75 ( EudraCT Number )
First Submitted: November 29, 2012
First Posted: December 6, 2012
Results First Submitted: December 28, 2016
Results First Posted: May 7, 2018
Last Update Posted: January 8, 2019