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Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma

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ClinicalTrials.gov Identifier: NCT01282463
Recruitment Status : Completed
First Posted : January 25, 2011
Results First Posted : July 2, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma of Urinary Tract
Urethral Carcinoma
Carcinoma of Ureter
Carcinoma of Renal Pelvis
Interventions Drug: Docetaxel
Biological: Ramucirumab DP
Biological: Icrucumab
Enrollment 148
Recruitment Details  
Pre-assignment Details Participants who died or discontinued treatment due to progressive disease (PD) were considered completers at the end of study. 8 participants were included in the "never treated" group due to death, PD, withdrawal, physician decision or protocol violation.
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Period Title: Overall Study
Started 49 49 50
Received at Least 1 Dose of Study Drug 45 46 49
Completed 41 45 46
Not Completed 8 4 4
Reason Not Completed
Lost to Follow-up             1             0             0
Withdrawal by Subject             6             2             3
Never Treated "Death"             0             1             0
Never Treated "PD"             0             1             0
Protocol Violation             0             0             1
Physician Decision             1             0             0
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab Total
Hide Arm/Group Description

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Total of all reporting groups
Overall Number of Baseline Participants 45 46 49 140
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 46 participants 49 participants 140 participants
66.6  (11.45) 66.7  (9.06) 64.1  (10.38) 65.7  (10.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 49 participants 140 participants
Female
10
  22.2%
9
  19.6%
11
  22.4%
30
  21.4%
Male
35
  77.8%
37
  80.4%
38
  77.6%
110
  78.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 49 participants 140 participants
Hispanic or Latino
4
   8.9%
3
   6.5%
2
   4.1%
9
   6.4%
Not Hispanic or Latino
41
  91.1%
43
  93.5%
47
  95.9%
131
  93.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 49 participants 140 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
  11.1%
2
   4.3%
4
   8.2%
11
   7.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   4.4%
0
   0.0%
2
   4.1%
4
   2.9%
White
36
  80.0%
43
  93.5%
42
  85.7%
121
  86.4%
More than one race
2
   4.4%
1
   2.2%
1
   2.0%
4
   2.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 49 participants 140 participants
Canada
30
  66.7%
28
  60.9%
37
  75.5%
95
  67.9%
United States
15
  33.3%
18
  39.1%
12
  24.5%
45
  32.1%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
Time Frame Randomization to Measured PD or Death From Any Cause (Up To 40 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug. Participants censored: docetaxel arm = 40; docetaxel and ramucirumab arm = 34; docetaxel and Icrucumab arm = 41.
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 45 46 49
Median (95% Confidence Interval)
Unit of Measure: months
2.8
(1.9 to 3.6)
5.4
(3.1 to 6.9)
1.6
(1.4 to 5.4)
2.Secondary Outcome
Title Percentage of Participants Achieving Objective Response Rate (ORR)
Hide Description Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)*100.
Time Frame Randomization to Measured PD (Up to 40 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received one dose of study drug.
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 45 46 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.9
(2.5 to 21.2)
23.9
(12.6 to 38.8)
12.2
(4.6 to 24.8)
3.Secondary Outcome
Title Duration of Response
Hide Description The duration of response was measured from the time measurement criteria were first met for a CR or PR (whichever was first recorded) until the first date of objectively documented progressive disease (taking as a reference for progressive disease the smallest measurement recorded since randomization) or the date of death, whichever occurred first. Data for participants who did not relapse or die were censored at the day of their last adequate tumor assessment. Duration of response was estimated by the Kaplan-Meier method.
Time Frame First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants received one dose of study drug and had CR or PR.
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 4 11 6
Median (95% Confidence Interval)
Unit of Measure: months
4.6
(2.6 to 5.6)
4.6
(0.7 to 7.0)
NA [1] 
(2.9 to NA)
[1]
The median and the upper limit was not estimable due to a small sample size and 2 participants had PD or Death.
4.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time Frame Up To 41.7 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 45 46 49
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE 45 46 49
Any SAE 19 25 22
5.Secondary Outcome
Title Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab
Hide Description [Not Specified]
Time Frame Cycle 1:Predose,1 hour(hr) post End of Infusion (EOI),48hr,72hr,168hr,336hr post-EOI;Cycle2:Predose,1hr post-EOI; Cycle3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI; Cycle4:Predose,1hr post-EOI;Cycle6 and every other cycle thereafter:Predose,1hr Post EOI
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm.
Arm/Group Title Docetaxel + Ramucirumab DP
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram/milliliter (ug/mL)
Cycle 1 Number Analyzed 8 participants
258
(27%)
Cycle 2 Number Analyzed 7 participants
304
(31%)
Cycle 3 Number Analyzed 3 participants
300
(13%)
Cycle 4 Number Analyzed 5 participants
279
(40%)
Cycle 6 Number Analyzed 3 participants
252
(57%)
6.Secondary Outcome
Title PK: Minimum Concentration (Cmin) Ramucirumab
Hide Description [Not Specified]
Time Frame Cycle 2:Predose,1hr post-EOI;Cycle3:Predose,1hr,48hr,72hr,168hr,336hr, post-EOI;Cycle4:Predose,1hr post-EOI;Cycle6:Predose,1hr Post EOI
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm.
Arm/Group Title Docetaxel + Ramucirumab DP
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Overall Number of Participants Analyzed 46
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram/milliliter (ug/mL)
Cycle 2 Number Analyzed 28 participants
19.5
(56%)
Cycle 3 Number Analyzed 6 participants
39.9
(34%)
Cycle 4 Number Analyzed 22 participants
35.3
(60%)
Cycle 6 Number Analyzed 4 participants
31.2
(61%)
7.Secondary Outcome
Title PK: Cmax Icrucumab
Hide Description [Not Specified]
Time Frame Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.
Arm/Group Title Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on Day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
Cycle 1 Cmax Number Analyzed 8 participants
474
(45%)
Cycle 3 Cmax Number Analyzed 4 participants
599
(27%)
8.Secondary Outcome
Title PK: Cmin Icrucumab
Hide Description [Not Specified]
Time Frame Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.
Arm/Group Title Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
Day 1 Cycle 2 Number Analyzed 1 participants
NA [1] 
(NA%)
Day 1 Cycle 3 Number Analyzed 4 participants
153
(66%)
[1]
Geometric Mean and Geometric Coefficient of Variation was not calculable due to n=1.
9.Secondary Outcome
Title Number of Participants With Serum Anti-Ramucirumab Antibody Assessment
Hide Description Number of participants with at least one positive titer treatment emergent antibody positive neutralizing antibody detecting. A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.
Time Frame Cycle 1:Predose,EOI,1hr,48hr,72hr,168hr,336 hr post-EOI:Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI;Cycle 4:Predose,1hr post-EOI;Cycle 6:Predose,1hr post-EOI
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and post baseline anti-ramucirumab antibodies.
Arm/Group Title Docetaxel + Ramucirumab DP
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
1
10.Secondary Outcome
Title Number of Participants With Serum Anti-Icrucumab Antibody Assessment
Hide Description A sample will be considered positive for anti-Icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-IMC-Icrucumab antibody level seen in healthy untreated individuals.
Time Frame Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Data not collected.
Arm/Group Title Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Pharmacodynamics (PD): Change in Circulating Levels of Placental Growth Factor (PlGF)
Hide Description [Not Specified]
Time Frame 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Data not collected.
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-A (VEGF-A)
Hide Description [Not Specified]
Time Frame 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Data not collected.
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-B (VEGF-B)
Hide Description [Not Specified]
Time Frame 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Data not collected.
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-1 (VEGFR-1)
Hide Description [Not Specified]
Time Frame 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Data not collected.
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-2 (VEGFR-2)
Hide Description [Not Specified]
Time Frame 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Data not collected.
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description:

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug.
 
Arm/Group Title Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Hide Arm/Group Description

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

All-Cause Mortality
Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/45 (42.22%)      25/46 (54.35%)      22/49 (44.90%)    
Blood and lymphatic system disorders       
Anaemia  1  2/45 (4.44%)  2 1/46 (2.17%)  1 2/49 (4.08%)  2
Febrile neutropenia  1  5/45 (11.11%)  6 9/46 (19.57%)  9 3/49 (6.12%)  3
Haemorrhagic anaemia  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Neutropenia  1  2/45 (4.44%)  3 4/46 (8.70%)  4 2/49 (4.08%)  2
Thrombocytopenia  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Cardiac disorders       
Atrial fibrillation  1  1/45 (2.22%)  1 0/46 (0.00%)  0 2/49 (4.08%)  2
Cardio-respiratory arrest  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Left ventricular dysfunction  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Pericardial effusion  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Tachycardia  1  1/45 (2.22%)  1 0/46 (0.00%)  0 1/49 (2.04%)  1
Gastrointestinal disorders       
Ascites  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Constipation  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Diarrhoea  1  0/45 (0.00%)  0 1/46 (2.17%)  1 1/49 (2.04%)  1
Duodenal perforation  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Duodenal ulcer  1  1/45 (2.22%)  1 0/46 (0.00%)  0 1/49 (2.04%)  1
Gastric ulcer  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Gastrointestinal ulcer haemorrhage  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Intestinal perforation  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Large intestinal obstruction  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Mouth haemorrhage  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Oesophagitis  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Pneumatosis intestinalis  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Small intestinal haemorrhage  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Small intestinal obstruction  1  1/45 (2.22%)  1 3/46 (6.52%)  3 1/49 (2.04%)  1
Stomatitis  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Vomiting  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
General disorders       
Asthenia  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Device occlusion  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Fatigue  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Local swelling  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Multi-organ failure  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Non-cardiac chest pain  1  0/45 (0.00%)  0 1/46 (2.17%)  1 1/49 (2.04%)  1
Pain  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Pyrexia  1  0/45 (0.00%)  0 3/46 (6.52%)  3 0/49 (0.00%)  0
Hepatobiliary disorders       
Hepatic fibrosis  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Infections and infestations       
Arteritis infective  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Bacteraemia  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Bronchopneumonia  1  0/45 (0.00%)  0 1/46 (2.17%)  1 1/49 (2.04%)  1
Escherichia bacteraemia  1  1/45 (2.22%)  2 0/46 (0.00%)  0 0/49 (0.00%)  0
Eye infection staphylococcal  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Gastroenteritis  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Influenza  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Klebsiella sepsis  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Lobar pneumonia  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Oral candidiasis  1  0/45 (0.00%)  0 2/46 (4.35%)  2 0/49 (0.00%)  0
Pneumonia  1  1/45 (2.22%)  1 4/46 (8.70%)  4 1/49 (2.04%)  1
Sepsis  1  2/45 (4.44%)  2 4/46 (8.70%)  4 0/49 (0.00%)  0
Septic shock  1  0/45 (0.00%)  0 1/46 (2.17%)  1 1/49 (2.04%)  1
Stoma site infection  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Urinary tract infection  1  1/45 (2.22%)  1 3/46 (6.52%)  3 3/49 (6.12%)  5
Urosepsis  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Injury, poisoning and procedural complications       
Fall  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Investigations       
Blood creatinine increased  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
White blood cell count decreased  1  1/45 (2.22%)  2 0/46 (0.00%)  0 0/49 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Dehydration  1  2/45 (4.44%)  2 1/46 (2.17%)  1 2/49 (4.08%)  2
Hypoglycaemia  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Hyponatraemia  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Hypovolaemia  1  0/45 (0.00%)  0 2/46 (4.35%)  2 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant pleural effusion  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Nervous system disorders       
Ischaemic stroke  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Paraesthesia  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Spinal cord compression  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Syncope  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Renal and urinary disorders       
Haematuria  1  2/45 (4.44%)  2 2/46 (4.35%)  2 1/49 (2.04%)  1
Renal failure  1  1/45 (2.22%)  1 0/46 (0.00%)  0 1/49 (2.04%)  1
Renal failure acute  1  0/45 (0.00%)  0 2/46 (4.35%)  2 1/49 (2.04%)  1
Renal tubular necrosis  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Urinary tract obstruction  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Dyspnoea  1  0/45 (0.00%)  0 1/46 (2.17%)  1 1/49 (2.04%)  1
Hypoxia  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Interstitial lung disease  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Lung infiltration  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Pleural effusion  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Pulmonary embolism  1  1/45 (2.22%)  1 0/46 (0.00%)  0 2/49 (4.08%)  2
Respiratory failure  1  1/45 (2.22%)  1 0/46 (0.00%)  0 2/49 (4.08%)  2
Skin and subcutaneous tissue disorders       
Swelling face  1  0/45 (0.00%)  0 0/46 (0.00%)  0 1/49 (2.04%)  1
Vascular disorders       
Accelerated hypertension  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Circulatory collapse  1  0/45 (0.00%)  0 1/46 (2.17%)  1 0/49 (0.00%)  0
Deep vein thrombosis  1  0/45 (0.00%)  0 0/46 (0.00%)  0 2/49 (4.08%)  2
Hypotension  1  1/45 (2.22%)  1 0/46 (0.00%)  0 1/49 (2.04%)  1
Phlebitis  1  1/45 (2.22%)  1 0/46 (0.00%)  0 0/49 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel Docetaxel + Ramucirumab DP Docetaxel + Icrucumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/45 (100.00%)      46/46 (100.00%)      49/49 (100.00%)    
Blood and lymphatic system disorders       
Anaemia  1  10/45 (22.22%)  14 11/46 (23.91%)  44 20/49 (40.82%)  49
Leukopenia  1  2/45 (4.44%)  3 2/46 (4.35%)  2 5/49 (10.20%)  14
Neutropenia  1  11/45 (24.44%)  18 9/46 (19.57%)  15 13/49 (26.53%)  25
Thrombocytopenia  1  4/45 (8.89%)  8 8/46 (17.39%)  23 3/49 (6.12%)  4
Cardiac disorders       
Tachycardia  1  3/45 (6.67%)  4 1/46 (2.17%)  1 1/49 (2.04%)  1
Eye disorders       
Lacrimation increased  1  3/45 (6.67%)  3 12/46 (26.09%)  18 5/49 (10.20%)  5
Vision blurred  1  2/45 (4.44%)  2 2/46 (4.35%)  2 4/49 (8.16%)  5
Gastrointestinal disorders       
Abdominal discomfort  1  1/45 (2.22%)  1 3/46 (6.52%)  3 1/49 (2.04%)  3
Abdominal pain  1  5/45 (11.11%)  5 10/46 (21.74%)  11 6/49 (12.24%)  6
Abdominal pain lower  1  2/45 (4.44%)  2 3/46 (6.52%)  4 0/49 (0.00%)  0
Abdominal pain upper  1  2/45 (4.44%)  2 3/46 (6.52%)  4 1/49 (2.04%)  3
Constipation  1  9/45 (20.00%)  14 9/46 (19.57%)  12 15/49 (30.61%)  17
Diarrhoea  1  11/45 (24.44%)  16 25/46 (54.35%)  44 22/49 (44.90%)  30
Dry mouth  1  3/45 (6.67%)  5 4/46 (8.70%)  4 5/49 (10.20%)  6
Dyspepsia  1  3/45 (6.67%)  4 3/46 (6.52%)  4 3/49 (6.12%)  3
Dysphagia  1  1/45 (2.22%)  1 5/46 (10.87%)  6 1/49 (2.04%)  2
Gastrooesophageal reflux disease  1  1/45 (2.22%)  1 1/46 (2.17%)  1 3/49 (6.12%)  4
Nausea  1  12/45 (26.67%)  19 24/46 (52.17%)  36 24/49 (48.98%)  40
Oral pain  1  0/45 (0.00%)  0 3/46 (6.52%)  3 0/49 (0.00%)  0
Stomatitis  1  7/45 (15.56%)  10 15/46 (32.61%)  29 4/49 (8.16%)  4
Vomiting  1  7/45 (15.56%)  7 14/46 (30.43%)  20 14/49 (28.57%)  21
General disorders       
Asthenia  1  2/45 (4.44%)  3 6/46 (13.04%)  7 3/49 (6.12%)  4
Chills  1  5/45 (11.11%)  5 7/46 (15.22%)  8 2/49 (4.08%)  3
Fatigue  1  36/45 (80.00%)  63 38/46 (82.61%)  108 38/49 (77.55%)  135
Influenza like illness  1  4/45 (8.89%)  5 2/46 (4.35%)  2 3/49 (6.12%)  3
Mucosal inflammation  1  4/45 (8.89%)  4 10/46 (21.74%)  19 3/49 (6.12%)  9
Non-cardiac chest pain  1  1/45 (2.22%)  1 5/46 (10.87%)  5 1/49 (2.04%)  1
Oedema peripheral  1  9/45 (20.00%)  10 17/46 (36.96%)  27 24/49 (48.98%)  49
Pain  1  1/45 (2.22%)  1 2/46 (4.35%)  5 3/49 (6.12%)  4
Peripheral swelling  1  2/45 (4.44%)  2 1/46 (2.17%)  1 5/49 (10.20%)  5
Pyrexia  1  5/45 (11.11%)  6 11/46 (23.91%)  14 11/49 (22.45%)  15
Infections and infestations       
Candida infection  1  4/45 (8.89%)  4 3/46 (6.52%)  4 2/49 (4.08%)  3
Oral candidiasis  1  3/45 (6.67%)  4 3/46 (6.52%)  3 1/49 (2.04%)  1
Pneumonia  1  3/45 (6.67%)  3 4/46 (8.70%)  4 1/49 (2.04%)  1
Rhinitis  1  2/45 (4.44%)  2 3/46 (6.52%)  3 0/49 (0.00%)  0
Upper respiratory tract infection  1  1/45 (2.22%)  1 2/46 (4.35%)  2 3/49 (6.12%)  4
Urinary tract infection  1  9/45 (20.00%)  10 9/46 (19.57%)  12 6/49 (12.24%)  9
Injury, poisoning and procedural complications       
Fall  1  3/45 (6.67%)  3 1/46 (2.17%)  1 1/49 (2.04%)  2
Infusion related reaction  1  2/45 (4.44%)  2 1/46 (2.17%)  1 6/49 (12.24%)  10
Investigations       
Blood creatinine increased  1  5/45 (11.11%)  7 3/46 (6.52%)  3 4/49 (8.16%)  8
Neutrophil count decreased  1  7/45 (15.56%)  15 6/46 (13.04%)  7 7/49 (14.29%)  20
Weight decreased  1  1/45 (2.22%)  1 7/46 (15.22%)  10 3/49 (6.12%)  4
Weight increased  1  0/45 (0.00%)  0 1/46 (2.17%)  2 5/49 (10.20%)  5
White blood cell count decreased  1  6/45 (13.33%)  6 1/46 (2.17%)  2 3/49 (6.12%)  4
Metabolism and nutrition disorders       
Decreased appetite  1  19/45 (42.22%)  30 26/46 (56.52%)  39 25/49 (51.02%)  41
Dehydration  1  6/45 (13.33%)  6 9/46 (19.57%)  14 10/49 (20.41%)  19
Hypoalbuminaemia  1  3/45 (6.67%)  3 2/46 (4.35%)  2 1/49 (2.04%)  1
Hypokalaemia  1  1/45 (2.22%)  1 2/46 (4.35%)  2 4/49 (8.16%)  5
Hypomagnesaemia  1  3/45 (6.67%)  4 2/46 (4.35%)  2 3/49 (6.12%)  4
Hyponatraemia  1  1/45 (2.22%)  1 1/46 (2.17%)  1 3/49 (6.12%)  7
Musculoskeletal and connective tissue disorders       
Arthralgia  1  11/45 (24.44%)  20 11/46 (23.91%)  17 12/49 (24.49%)  17
Back pain  1  7/45 (15.56%)  8 6/46 (13.04%)  10 7/49 (14.29%)  9
Bone pain  1  2/45 (4.44%)  2 5/46 (10.87%)  9 1/49 (2.04%)  1
Flank pain  1  3/45 (6.67%)  3 3/46 (6.52%)  3 2/49 (4.08%)  4
Groin pain  1  1/45 (2.22%)  1 3/46 (6.52%)  3 1/49 (2.04%)  1
Muscle spasms  1  3/45 (6.67%)  3 0/46 (0.00%)  0 2/49 (4.08%)  2
Muscular weakness  1  4/45 (8.89%)  4 8/46 (17.39%)  19 7/49 (14.29%)  10
Musculoskeletal chest pain  1  1/45 (2.22%)  1 3/46 (6.52%)  3 3/49 (6.12%)  5
Musculoskeletal pain  1  2/45 (4.44%)  2 2/46 (4.35%)  3 4/49 (8.16%)  5
Myalgia  1  6/45 (13.33%)  8 12/46 (26.09%)  30 7/49 (14.29%)  11
Pain in extremity  1  2/45 (4.44%)  2 7/46 (15.22%)  11 7/49 (14.29%)  10
Nervous system disorders       
Dizziness  1  3/45 (6.67%)  6 8/46 (17.39%)  12 10/49 (20.41%)  11
Dysgeusia  1  17/45 (37.78%)  25 14/46 (30.43%)  26 16/49 (32.65%)  32
Headache  1  3/45 (6.67%)  5 9/46 (19.57%)  13 6/49 (12.24%)  6
Hypoaesthesia  1  1/45 (2.22%)  1 3/46 (6.52%)  3 2/49 (4.08%)  3
Neuropathy peripheral  1  6/45 (13.33%)  6 11/46 (23.91%)  21 8/49 (16.33%)  14
Paraesthesia  1  6/45 (13.33%)  6 7/46 (15.22%)  8 4/49 (8.16%)  5
Peripheral sensory neuropathy  1  6/45 (13.33%)  11 7/46 (15.22%)  8 6/49 (12.24%)  8
Psychiatric disorders       
Anxiety  1  2/45 (4.44%)  2 1/46 (2.17%)  1 4/49 (8.16%)  4
Depression  1  0/45 (0.00%)  0 5/46 (10.87%)  5 2/49 (4.08%)  2
Insomnia  1  4/45 (8.89%)  4 10/46 (21.74%)  16 17/49 (34.69%)  26
Renal and urinary disorders       
Haematuria  1  2/45 (4.44%)  4 15/46 (32.61%)  37 4/49 (8.16%)  7
Hydronephrosis  1  0/45 (0.00%)  0 4/46 (8.70%)  4 1/49 (2.04%)  1
Proteinuria  1  1/45 (2.22%)  5 3/46 (6.52%)  4 5/49 (10.20%)  6
Urinary retention  1  2/45 (4.44%)  2 4/46 (8.70%)  6 1/49 (2.04%)  1
Reproductive system and breast disorders       
Scrotal oedema  1  1/35 (2.86%)  1 3/37 (8.11%)  4 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  4/45 (8.89%)  8 18/46 (39.13%)  23 16/49 (32.65%)  19
Dysphonia  1  0/45 (0.00%)  0 3/46 (6.52%)  3 1/49 (2.04%)  1
Dyspnoea  1  11/45 (24.44%)  14 12/46 (26.09%)  16 16/49 (32.65%)  25
Dyspnoea exertional  1  1/45 (2.22%)  1 4/46 (8.70%)  5 5/49 (10.20%)  8
Epistaxis  1  4/45 (8.89%)  4 20/46 (43.48%)  23 0/49 (0.00%)  0
Hiccups  1  4/45 (8.89%)  4 3/46 (6.52%)  3 2/49 (4.08%)  3
Nasal congestion  1  0/45 (0.00%)  0 6/46 (13.04%)  7 3/49 (6.12%)  4
Oropharyngeal pain  1  5/45 (11.11%)  5 10/46 (21.74%)  11 1/49 (2.04%)  1
Pleural effusion  1  1/45 (2.22%)  1 5/46 (10.87%)  7 3/49 (6.12%)  4
Pulmonary embolism  1  2/45 (4.44%)  2 0/46 (0.00%)  0 3/49 (6.12%)  3
Rhinorrhoea  1  1/45 (2.22%)  1 5/46 (10.87%)  5 1/49 (2.04%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1  22/45 (48.89%)  28 27/46 (58.70%)  34 26/49 (53.06%)  30
Dermatitis acneiform  1  3/45 (6.67%)  3 2/46 (4.35%)  3 0/49 (0.00%)  0
Dry skin  1  1/45 (2.22%)  1 5/46 (10.87%)  7 2/49 (4.08%)  2
Ecchymosis  1  3/45 (6.67%)  3 0/46 (0.00%)  0 0/49 (0.00%)  0
Erythema  1  0/45 (0.00%)  0 3/46 (6.52%)  4 1/49 (2.04%)  1
Nail discolouration  1  3/45 (6.67%)  3 5/46 (10.87%)  5 1/49 (2.04%)  1
Nail disorder  1  4/45 (8.89%)  4 2/46 (4.35%)  2 1/49 (2.04%)  1
Palmar-plantar erythrodysaesthesia syndrome  1  1/45 (2.22%)  1 4/46 (8.70%)  5 0/49 (0.00%)  0
Pruritus  1  3/45 (6.67%)  4 1/46 (2.17%)  1 1/49 (2.04%)  2
Rash  1  2/45 (4.44%)  2 3/46 (6.52%)  4 1/49 (2.04%)  1
Rash maculo-papular  1  8/45 (17.78%)  12 3/46 (6.52%)  5 4/49 (8.16%)  6
Vascular disorders       
Flushing  1  1/45 (2.22%)  1 3/46 (6.52%)  4 5/49 (10.20%)  5
Hypertension  1  3/45 (6.67%)  8 10/46 (21.74%)  15 1/49 (2.04%)  1
Hypotension  1  5/45 (11.11%)  8 8/46 (17.39%)  8 3/49 (6.12%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01282463    
Other Study ID Numbers: 13943
CP20-0902 ( Other Identifier: ImClone Systems )
I4Y-IE-JCDC ( Other Identifier: Eli Lilly and Company )
First Submitted: January 21, 2011
First Posted: January 25, 2011
Results First Submitted: June 13, 2019
Results First Posted: July 2, 2019
Last Update Posted: September 9, 2019