Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Ramucirumab (IMC-1121B) and Paclitaxel in Participants With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01515306
Recruitment Status : Active, not recruiting
First Posted : January 24, 2012
Results First Posted : June 18, 2014
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Solid Tumor
Interventions Biological: ramucirumab (IMC-1121B)
Drug: paclitaxel
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A: Paclitaxel and Ramucirumab (IMC-1121B) Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel
Hide Arm/Group Description

Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.

Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle.

Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.

Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A.

Period Title: Overall Study
Started 24 16
Received at Least 1 Dose of Study Drug 24 16
Drug-Drug Interaction Population 21 [1] 0 [2]
Completed 12 [3] 2
Not Completed 12 14
Reason Not Completed
Adverse Event             2             0
Progressive Disease             1             0
Ongoing receiving treatment             9             14
[1]
Completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment.
[2]
Drug-drug interaction was only assessed in Part A.
[3]
Completed the required treatment in Cycle 1 Day 1 and Cycle 2 Day 1 and assessment.
Arm/Group Title Part A: Paclitaxel and Ramucirumab (IMC-1121B) Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel Total
Hide Arm/Group Description

Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.

Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle.

Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.

Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A.

Total of all reporting groups
Overall Number of Baseline Participants 24 16 40
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 16 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  58.3%
10
  62.5%
24
  60.0%
>=65 years
10
  41.7%
6
  37.5%
16
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 16 participants 40 participants
Female
13
  54.2%
9
  56.3%
22
  55.0%
Male
11
  45.8%
7
  43.8%
18
  45.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 16 participants 40 participants
Hispanic or Latino
1
   4.2%
0
   0.0%
1
   2.5%
Not Hispanic or Latino
23
  95.8%
16
 100.0%
39
  97.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 16 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.2%
1
   6.3%
2
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
22
  91.7%
15
  93.8%
37
  92.5%
More than one race
1
   4.2%
0
   0.0%
1
   2.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 16 participants 40 participants
24 16 40
1.Primary Outcome
Title Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1
Hide Description Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Time Frame Cycle 1: 0, 1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel AUC(0-∞) in Cycle 1.
Arm/Group Title Part A: Paclitaxel (Cycle 1)
Hide Arm/Group Description:
Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
Overall Number of Participants Analyzed 19
Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanograms*hour/milliliter/milligram
29
(24.50 to 34.34)
2.Primary Outcome
Title Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2
Hide Description Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Time Frame Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel AUC(0-∞) in Cycle 2.
Arm/Group Title Part A: Paclitaxel (Cycle 2)
Hide Arm/Group Description:

Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.

Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

Overall Number of Participants Analyzed 17
Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanograms*hour/milliliter/milligram
31.67
(26.58 to 37.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Paclitaxel (Cycle 2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1.
Method of Estimation Estimation Parameter Ratio of Geo LS means
Estimated Value 1.09
Confidence Interval (2-Sided) 90%
0.93 to 1.29
Estimation Comments [Not Specified]
3.Primary Outcome
Title Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1
Hide Description Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Time Frame Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel Cmax in Cycle 1.
Arm/Group Title Part A: Paclitaxel (Cycle 1)
Hide Arm/Group Description:
Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
Overall Number of Participants Analyzed 21
Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanograms/milliliter/milligram
18.84
(16.03 to 22.13)
4.Primary Outcome
Title Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2
Hide Description Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Time Frame Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel Cmax in Cycle 2.
Arm/Group Title Part A: Paclitaxel (Cycle 2)
Hide Arm/Group Description:

Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.

Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

Overall Number of Participants Analyzed 20
Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanograms/milliliter/milligram
18.30
(15.54 to 21.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Paclitaxel (Cycle 2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.
Method of Estimation Estimation Parameter Ratio of Geo LS means
Estimated Value 0.97
Confidence Interval (2-Sided) 90%
0.83 to 1.13
Estimation Comments [Not Specified]
5.Primary Outcome
Title Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy
Hide Description Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.
Time Frame Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72,168, 264, 336, 408, and 504 hours post ramucirumab infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 1 of Part B.
Arm/Group Title Part B: Ramucirumab (IMC-1121B) (Cycle 1)
Hide Arm/Group Description:
Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms*hour/milliliter/milligram
55.3
(27%)
6.Secondary Outcome
Title Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel
Hide Description Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.
Time Frame Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2 of Part A.
Arm/Group Title Part A: Ramucirumab (IMC-1121B) (Cycle 2)
Hide Arm/Group Description:

Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.

Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

Overall Number of Participants Analyzed 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms*hour/milliliters/milligram
55.4
(27%)
7.Secondary Outcome
Title Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel
Hide Description Dose-normalized Cmax was calculated from Cmax divided by the dose.
Time Frame Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2 of Part A.
Arm/Group Title Part A: Ramucirumab (IMC-1121B) (Cycle 2)
Hide Arm/Group Description:

Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.

Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

Overall Number of Participants Analyzed 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms/milliliter/milligram
0.384
(31%)
8.Secondary Outcome
Title Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Incidence of Anti-Ramucirumab Antibodies
Hide Description [Not Specified]
Time Frame -1 hour on Day 1 of Cycle 2, and 30 days after last dose of study drug
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Part B: Immunogenicity of Ramucirumab as Monotherapy - Incidence of Anti-Ramucirumab Antibodies
Hide Description [Not Specified]
Time Frame 0 hour on Day 1 of Cycle 1, and 30 days after last dose of study drug
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Deaths due to progressive disease were not considered adverse events (AEs).
 
Arm/Group Title Part A: Paclitaxel and Ramucirumab (IMC-1121B) Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel
Hide Arm/Group Description

Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.

Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle.

Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.

Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A.

All-Cause Mortality
Part A: Paclitaxel and Ramucirumab (IMC-1121B) Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part A: Paclitaxel and Ramucirumab (IMC-1121B) Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/24 (20.83%)      0/16 (0.00%)    
General disorders     
Non-cardiac chest pain  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Pyrexia  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Hepatobiliary disorders     
Acute hepatic failure  1 [1]  1/24 (4.17%)  1 0/16 (0.00%)  0
Infections and infestations     
Influenza  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Investigations     
Hepatic enzyme increased  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Nervous system disorders     
Depressed level of consciousness  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Renal and urinary disorders     
Renal failure acute  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Dyspnoea  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Pulmonary embolism  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hypoaesthesia facial  1  1/24 (4.17%)  1 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
[1]
Event resulted in death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: Paclitaxel and Ramucirumab (IMC-1121B) Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/24 (100.00%)      11/16 (68.75%)    
Blood and lymphatic system disorders     
Anaemia  1  10/24 (41.67%)  15 0/16 (0.00%)  0
Neutropenia  1  4/24 (16.67%)  11 0/16 (0.00%)  0
Thrombocytopenia  1  2/24 (8.33%)  3 0/16 (0.00%)  0
Eye disorders     
Vision blurred  1  3/24 (12.50%)  3 0/16 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  4/24 (16.67%)  4 2/16 (12.50%)  2
Ascites  1  0/24 (0.00%)  0 1/16 (6.25%)  2
Breath odour  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Constipation  1  6/24 (25.00%)  6 1/16 (6.25%)  1
Defaecation urgency  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Diarrhoea  1  7/24 (29.17%)  9 2/16 (12.50%)  2
Dry mouth  1  2/24 (8.33%)  2 2/16 (12.50%)  2
Dysphagia  1  2/24 (8.33%)  2 0/16 (0.00%)  0
Nausea  1  6/24 (25.00%)  9 3/16 (18.75%)  3
Stomatitis  1  3/24 (12.50%)  4 2/16 (12.50%)  2
Vomiting  1  4/24 (16.67%)  6 1/16 (6.25%)  1
General disorders     
Asthenia  1  2/24 (8.33%)  3 0/16 (0.00%)  0
Catheter site pain  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Chills  1  2/24 (8.33%)  2 0/16 (0.00%)  0
Face oedema  1  2/24 (8.33%)  2 1/16 (6.25%)  1
Fatigue  1  12/24 (50.00%)  15 2/16 (12.50%)  2
Gait disturbance  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Localised oedema  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Non-cardiac chest pain  1  1/24 (4.17%)  1 1/16 (6.25%)  2
Oedema peripheral  1  4/24 (16.67%)  6 1/16 (6.25%)  1
Pyrexia  1  4/24 (16.67%)  5 0/16 (0.00%)  0
Infections and infestations     
Cellulitis  1  1/24 (4.17%)  2 1/16 (6.25%)  1
Sinusitis  1  1/24 (4.17%)  1 1/16 (6.25%)  1
Upper respiratory tract infection  1  4/24 (16.67%)  5 0/16 (0.00%)  0
Urinary tract infection  1  1/24 (4.17%)  1 2/16 (12.50%)  2
Injury, poisoning and procedural complications     
Excoriation  1  1/24 (4.17%)  1 1/16 (6.25%)  1
Infusion related reaction  1  3/24 (12.50%)  3 1/16 (6.25%)  1
Investigations     
Aspartate aminotransferase increased  1  2/24 (8.33%)  2 1/16 (6.25%)  1
Blood creatinine increased  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Lymphocyte count decreased  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Neutrophil count decreased  1  2/24 (8.33%)  2 0/16 (0.00%)  0
Weight decreased  1  3/24 (12.50%)  4 1/16 (6.25%)  1
White blood cell count decreased  1  2/24 (8.33%)  2 0/16 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  7/24 (29.17%)  9 2/16 (12.50%)  2
Dehydration  1  1/24 (4.17%)  1 1/16 (6.25%)  1
Hyperglycaemia  1  1/24 (4.17%)  1 2/16 (12.50%)  2
Hyponatraemia  1  1/24 (4.17%)  1 1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/24 (12.50%)  3 0/16 (0.00%)  0
Back pain  1  4/24 (16.67%)  4 0/16 (0.00%)  0
Flank pain  1  1/24 (4.17%)  1 1/16 (6.25%)  1
Joint range of motion decreased  1  2/24 (8.33%)  2 0/16 (0.00%)  0
Musculoskeletal chest pain  1  2/24 (8.33%)  2 0/16 (0.00%)  0
Musculoskeletal discomfort  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Musculoskeletal pain  1  2/24 (8.33%)  2 2/16 (12.50%)  2
Myalgia  1  4/24 (16.67%)  4 0/16 (0.00%)  0
Pain in extremity  1  2/24 (8.33%)  2 0/16 (0.00%)  0
Nervous system disorders     
Dizziness  1  5/24 (20.83%)  5 1/16 (6.25%)  1
Dysarthria  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Dysgeusia  1  4/24 (16.67%)  4 0/16 (0.00%)  0
Headache  1  5/24 (20.83%)  7 2/16 (12.50%)  2
Neuralgia  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Neuropathy peripheral  1  4/24 (16.67%)  4 0/16 (0.00%)  0
Paraesthesia  1  2/24 (8.33%)  2 1/16 (6.25%)  1
Somnolence  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Psychiatric disorders     
Anxiety  1  2/24 (8.33%)  2 0/16 (0.00%)  0
Insomnia  1  1/24 (4.17%)  1 3/16 (18.75%)  3
Renal and urinary disorders     
Proteinuria  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Reproductive system and breast disorders     
Breast pain  1  0/24 (0.00%)  0 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/24 (12.50%)  5 0/16 (0.00%)  0
Dyspnoea  1  4/24 (16.67%)  4 0/16 (0.00%)  0
Epistaxis  1  7/24 (29.17%)  7 4/16 (25.00%)  4
Haemoptysis  1  2/24 (8.33%)  4 0/16 (0.00%)  0
Nasal congestion  1  2/24 (8.33%)  2 0/16 (0.00%)  0
Sinus congestion  1  2/24 (8.33%)  2 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  6/24 (25.00%)  6 1/16 (6.25%)  1
Dry skin  1  3/24 (12.50%)  3 0/16 (0.00%)  0
Pruritus  1  3/24 (12.50%)  3 0/16 (0.00%)  0
Vascular disorders     
Flushing  1  3/24 (12.50%)  3 0/16 (0.00%)  0
Hypertension  1  5/24 (20.83%)  6 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01515306     History of Changes
Other Study ID Numbers: 14432
I4T-IE-JVCA ( Other Identifier: Eli Lilly and Company )
CP12-1032 ( Other Identifier: ImClone Systems )
First Submitted: January 18, 2012
First Posted: January 24, 2012
Results First Submitted: May 16, 2014
Results First Posted: June 18, 2014
Last Update Posted: August 8, 2018