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Trial record 93 of 157 for:    eribulin

A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Participants With Breast Cancer

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ClinicalTrials.gov Identifier: NCT01427933
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : August 19, 2014
Last Update Posted : February 6, 2017
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
Condition Breast Cancer
Interventions Biological: Ramucirumab (IMC-1121B)
Drug: Eribulin
Enrollment 141
Recruitment Details  
Pre-assignment Details Participant Flow reports participants who discontinued from the study. Participants who died due to any cause and participants who were alive at conclusion of the study but off treatment were considered to have completed the study.
Arm/Group Title Ramucirumab and Eribulin Eribulin Monotherapy
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Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Period Title: Overall Study
Started 71 70
Received at Least 1 Dose of Study Drug 69 65
Completed 63 57
Not Completed 8 13
Reason Not Completed
Withdrawal by Subject             5             8
Lost to Follow-up             1             5
Not Specified             1             0
Investigator's Decision             1             0
Arm/Group Title Ramucirumab and Eribulin Eribulin Monotherapy Total
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Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle Total of all reporting groups
Overall Number of Baseline Participants 71 70 141
Hide Baseline Analysis Population Description
All randomized participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 70 participants 141 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
62
  87.3%
53
  75.7%
115
  81.6%
>=65 years
9
  12.7%
17
  24.3%
26
  18.4%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 70 participants 141 participants
Female
71
 100.0%
70
 100.0%
141
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 70 participants 141 participants
Hispanic or Latino
5
   7.0%
3
   4.3%
8
   5.7%
Not Hispanic or Latino
65
  91.5%
67
  95.7%
132
  93.6%
Unknown or Not Reported
1
   1.4%
0
   0.0%
1
   0.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 70 participants 141 participants
American Indian or Alaska Native 0 1 1
Asian 1 1 2
Black or African American 11 8 19
White 54 58 112
Other 5 2 7
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants 70 participants 141 participants
71 70 141
1.Primary Outcome
Title Progression‐Free Survival (PFS)
Hide Description PFS was defined as time from date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter (SOD) of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff date were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.
Time Frame Start of treatment until documented disease progression or death from any cause up to 16.5 months
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Hide Analysis Population Description
Intent-to-treat Population (ITT): all participants according to their randomized treatment group. Participants censored: Ramucirumab+Eribulin=14; Eribulin=17.
Arm/Group Title Ramucirumab and Eribulin Eribulin Monotherapy
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Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Overall Number of Participants Analyzed 71 70
Median (95% Confidence Interval)
Unit of Measure: months
4.4
(3.1 to 6.7)
4.1
(3.2 to 5.6)
2.Secondary Outcome
Title Overall Survival (OS) Randomization to Date of Death From Any Cause
Hide Description Time from the date of randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date, OS data were censored on the last date the participants were known to be alive prior to that cut-off date.
Time Frame Randomization to date of death from any cause up to 28.6 months
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Hide Analysis Population Description
ITT Population: All randomized participants. Participants censored: Ramucirumab and Eribulin=24 , Eribulin Monotherapy=28
Arm/Group Title Ramucirumab and Eribulin Eribulin Monotherapy
Hide Arm/Group Description:

Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Overall Number of Participants Analyzed 71 70
Median (95% Confidence Interval)
Unit of Measure: Months
13.5
(10.4 to 17.9)
11.5
(9.0 to 17.3)
3.Secondary Outcome
Title Objective Response Rate (ORR) Percentage of Participants With Measurable Disease Achieving a Best Overall Response of Partial Response (PR) or Complete Response (CR)
Hide Description ORR was defined as the percentage of participants with measurable disease achieving a best overall response of PR or CR as defined by RECIST v.1.1. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in SOD of target lesions. Participants who did not have any post baseline tumor response assessments for any reason were considered non-responders and included in the denominator when calculating the response rate. ORR for each treatment arm calculated as: [(CR + PR in the treatment arm) divided by (total number of participants in the treatment arm)] x 100.
Time Frame Start of treatment until documented CR or PR up to 16.5 months
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Hide Analysis Population Description
ITT population: all participants according to their randomized treatment group.
Arm/Group Title Ramucirumab and Eribulin Eribulin Monotherapy
Hide Arm/Group Description:

Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Overall Number of Participants Analyzed 71 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.7
(11.2 to 30.9)
24.3
(14.8 to 36.0)
4.Secondary Outcome
Title Duration of Response (DOR) Time of Response to Progressive Disease
Hide Description DOR was measured from the time criteria were met for first objectively recorded CR or PR until first date criteria for PD was met or death. Response defined using RECIST v1.1 criteria. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of diameter (SOD) of target lesions. PD defined ≥20% increase in SOD of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.
Time Frame Time from Observed CR or PR to PD up to 12.1 months
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Hide Analysis Population Description
ITT population: all participants according to their randomized treatment group and who had CR or PR. Participants censored: Ramucirumab+Eribulin=1, Eribulin=3.
Arm/Group Title Ramucirumab and Eribulin Eribulin Monotherapy
Hide Arm/Group Description:

Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Overall Number of Participants Analyzed 14 17
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(3.1 to 7.1)
3.0
(1.4 to 4.4)
5.Secondary Outcome
Title Change in Tumor Size (CTS)
Hide Description CTS was defines as the change from baseline measurement of target lesions to the post treatment measurement in participants with measurable disease. Change was assessed using radiographic imagining. Log ratio calculated as: log of (tumor size post baseline) divided by (tumor size at baseline). A negative result indicated a shrinking tumor.
Time Frame Baseline, 6 weeks
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Hide Analysis Population Description
All participants with measurable disease at baseline and at 6 weeks.
Arm/Group Title Ramucirumab and Eribulin Eribulin Monotherapy
Hide Arm/Group Description:

Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Overall Number of Participants Analyzed 43 39
Mean (Standard Deviation)
Unit of Measure: log ratio
-0.20  (0.33) -0.20  (0.28)
6.Secondary Outcome
Title Number of Participants With Anti-Ramucirumab Antibodies
Hide Description The number of participants who developed treatment-emergent antibody responses after baseline. The antibody test can produce positive results in participants without ramucirumab exposure. Treatment emergent anti-ramucirumab antibody positive was defined as: when baseline titer was greater than 0 and post baseline titer was equal to or greater than 4-fold the baseline titer or if the baseline titer was not detected and post baseline titer is equal to or greater than a value of 20.
Time Frame Day 1 of Cycle 1, Cycle 3, Cycle 5 and 30 days after last dose of study drug up to 17.7 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and assessed for treatment emergent antibodies.
Arm/Group Title Ramucirumab and Eribulin Eribulin Monotherapy
Hide Arm/Group Description:

Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Overall Number of Participants Analyzed 61 41
Measure Type: Number
Unit of Measure: participants
4 2
7.Other Pre-specified Outcome
Title Number of Participants With Adverse Events (AE) and Participants Who Died
Hide Description Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Time Frame Baseline up to end of treatment and within 30 days of last dose of study drug (22.6 months)
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Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and according to the treatment received.
Arm/Group Title Ramucirumab and Eribulin Eribulin Monotherapy
Hide Arm/Group Description:

Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Overall Number of Participants Analyzed 69 65
Measure Type: Number
Unit of Measure: participants
SAE 26 12
Other non-SAE 68 65
Died 30 32
Time Frame [Not Specified]
Adverse Event Reporting Description SAE's and other non-SAE's are treatment emergent.
 
Arm/Group Title Ramucirumab and Eribulin Eribulin Monotherapy
Hide Arm/Group Description

Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
All-Cause Mortality
Ramucirumab and Eribulin Eribulin Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ramucirumab and Eribulin Eribulin Monotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/69 (37.68%)      12/65 (18.46%)    
Blood and lymphatic system disorders     
Anaemia  1  2/69 (2.90%)  2 0/65 (0.00%)  0
Febrile neutropenia  1  3/69 (4.35%)  3 1/65 (1.54%)  1
Neutropenia  1  4/69 (5.80%)  4 1/65 (1.54%)  1
Cardiac disorders     
Cardiac arrest  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Cardiac failure congestive  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Cardiac tamponade  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Pericardial effusion  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/69 (1.45%)  2 2/65 (3.08%)  2
Ascites  1  2/69 (2.90%)  2 2/65 (3.08%)  2
Colitis  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Gastritis  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Gastritis erosive  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Gastrointestinal haemorrhage  1  1/69 (1.45%)  2 0/65 (0.00%)  0
Ileus  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Nausea  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Odynophagia  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Pancreatitis  1  2/69 (2.90%)  3 0/65 (0.00%)  0
Small intestinal obstruction  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Stomatitis  1  2/69 (2.90%)  2 0/65 (0.00%)  0
General disorders     
Drug withdrawal syndrome  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Fatigue  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Mucosal inflammation  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Non-cardiac chest pain  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Oedema  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Pain  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Hepatobiliary disorders     
Cholecystitis acute  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Hepatic failure  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Infections and infestations     
Bacteraemia  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Cellulitis  1  2/69 (2.90%)  2 0/65 (0.00%)  0
Clostridium difficile colitis  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Escherichia urinary tract infection  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Peritonitis  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Peritonitis bacterial  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Pleural infection  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Pneumonia  1  2/69 (2.90%)  2 0/65 (0.00%)  0
Septic shock  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Systemic candida  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Urinary tract infection  1  1/69 (1.45%)  1 1/65 (1.54%)  2
Injury, poisoning and procedural complications     
Fall  1  1/69 (1.45%)  1 1/65 (1.54%)  1
Subdural haematoma  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Wound dehiscence  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Investigations     
Neutrophil count decreased  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Dehydration  1  3/69 (4.35%)  3 0/65 (0.00%)  0
Hyperglycaemia  1  1/69 (1.45%)  2 0/65 (0.00%)  0
Hypokalaemia  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Musculoskeletal discomfort  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Nervous system disorders     
Syncope  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Renal and urinary disorders     
Renal failure  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Renal failure acute  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Pulmonary embolism  1  2/69 (2.90%)  2 1/65 (1.54%)  1
Respiratory failure  1  2/69 (2.90%)  2 0/65 (0.00%)  0
Skin and subcutaneous tissue disorders     
Swelling face  1  0/69 (0.00%)  0 1/65 (1.54%)  1
Vascular disorders     
Hypotension  1  1/69 (1.45%)  1 0/65 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ramucirumab and Eribulin Eribulin Monotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/69 (97.10%)      64/65 (98.46%)    
Blood and lymphatic system disorders     
Anaemia  1  13/69 (18.84%)  20 16/65 (24.62%)  37
Leukopenia  1  4/69 (5.80%)  15 8/65 (12.31%)  31
Neutropenia  1  27/69 (39.13%)  71 29/65 (44.62%)  75
Thrombocytopenia  1  8/69 (11.59%)  17 4/65 (6.15%)  13
Gastrointestinal disorders     
Abdominal distension  1  4/69 (5.80%)  6 3/65 (4.62%)  3
Abdominal pain  1  9/69 (13.04%)  17 9/65 (13.85%)  9
Abdominal pain upper  1  4/69 (5.80%)  5 0/65 (0.00%)  0
Ascites  1  4/69 (5.80%)  5 0/65 (0.00%)  0
Constipation  1  20/69 (28.99%)  25 19/65 (29.23%)  21
Diarrhoea  1  17/69 (24.64%)  21 10/65 (15.38%)  19
Dyspepsia  1  5/69 (7.25%)  7 6/65 (9.23%)  7
Gastrooesophageal reflux disease  1  4/69 (5.80%)  4 4/65 (6.15%)  4
Nausea  1  28/69 (40.58%)  48 27/65 (41.54%)  41
Stomatitis  1  8/69 (11.59%)  11 4/65 (6.15%)  7
Vomiting  1  19/69 (27.54%)  32 17/65 (26.15%)  24
General disorders     
Asthenia  1  4/69 (5.80%)  6 2/65 (3.08%)  4
Fatigue  1  43/69 (62.32%)  77 38/65 (58.46%)  53
Local swelling  1  3/69 (4.35%)  4 4/65 (6.15%)  5
Mucosal inflammation  1  6/69 (8.70%)  7 3/65 (4.62%)  3
Oedema peripheral  1  10/69 (14.49%)  13 11/65 (16.92%)  12
Pain  1  5/69 (7.25%)  6 4/65 (6.15%)  4
Pyrexia  1  14/69 (20.29%)  21 5/65 (7.69%)  9
Immune system disorders     
Seasonal allergy  1  4/69 (5.80%)  4 2/65 (3.08%)  2
Infections and infestations     
Sinusitis  1  7/69 (10.14%)  10 1/65 (1.54%)  1
Upper respiratory tract infection  1  6/69 (8.70%)  6 9/65 (13.85%)  9
Urinary tract infection  1  2/69 (2.90%)  2 7/65 (10.77%)  7
Investigations     
Alanine aminotransferase increased  1  10/69 (14.49%)  11 5/65 (7.69%)  6
Aspartate aminotransferase increased  1  10/69 (14.49%)  12 6/65 (9.23%)  9
Blood alkaline phosphatase increased  1  4/69 (5.80%)  4 5/65 (7.69%)  7
Neutrophil count decreased  1  5/69 (7.25%)  19 8/65 (12.31%)  27
Weight decreased  1  4/69 (5.80%)  4 2/65 (3.08%)  3
White blood cell count decreased  1  6/69 (8.70%)  17 1/65 (1.54%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  19/69 (27.54%)  20 12/65 (18.46%)  13
Dehydration  1  10/69 (14.49%)  15 7/65 (10.77%)  8
Hyperglycaemia  1  4/69 (5.80%)  12 1/65 (1.54%)  1
Hypokalaemia  1  6/69 (8.70%)  9 7/65 (10.77%)  8
Hypomagnesaemia  1  4/69 (5.80%)  6 4/65 (6.15%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/69 (4.35%)  4 8/65 (12.31%)  11
Back pain  1  9/69 (13.04%)  9 4/65 (6.15%)  12
Bone pain  1  7/69 (10.14%)  9 4/65 (6.15%)  4
Muscle spasms  1  3/69 (4.35%)  3 4/65 (6.15%)  4
Muscular weakness  1  4/69 (5.80%)  6 3/65 (4.62%)  4
Musculoskeletal chest pain  1  1/69 (1.45%)  2 4/65 (6.15%)  7
Musculoskeletal pain  1  6/69 (8.70%)  6 4/65 (6.15%)  4
Myalgia  1  2/69 (2.90%)  2 6/65 (9.23%)  6
Pain in extremity  1  8/69 (11.59%)  8 5/65 (7.69%)  10
Nervous system disorders     
Dizziness  1  8/69 (11.59%)  10 7/65 (10.77%)  8
Dysgeusia  1  6/69 (8.70%)  6 4/65 (6.15%)  5
Headache  1  27/69 (39.13%)  39 10/65 (15.38%)  16
Hypoaesthesia  1  2/69 (2.90%)  2 4/65 (6.15%)  4
Peripheral motor neuropathy  1  2/69 (2.90%)  3 5/65 (7.69%)  8
Peripheral sensory neuropathy  1  15/69 (21.74%)  23 17/65 (26.15%)  30
Psychiatric disorders     
Anxiety  1  4/69 (5.80%)  7 3/65 (4.62%)  3
Depression  1  3/69 (4.35%)  4 6/65 (9.23%)  7
Insomnia  1  9/69 (13.04%)  9 6/65 (9.23%)  6
Renal and urinary disorders     
Proteinuria  1  4/69 (5.80%)  4 3/65 (4.62%)  3
Respiratory, thoracic and mediastinal disorders     
Cough  1  12/69 (17.39%)  12 12/65 (18.46%)  15
Dyspnoea  1  14/69 (20.29%)  18 14/65 (21.54%)  21
Dyspnoea exertional  1  5/69 (7.25%)  5 2/65 (3.08%)  3
Epistaxis  1  7/69 (10.14%)  8 2/65 (3.08%)  2
Oropharyngeal pain  1  6/69 (8.70%)  6 3/65 (4.62%)  5
Pleural effusion  1  4/69 (5.80%)  4 2/65 (3.08%)  3
Skin and subcutaneous tissue disorders     
Alopecia  1  20/69 (28.99%)  22 15/65 (23.08%)  16
Pruritus  1  4/69 (5.80%)  4 4/65 (6.15%)  5
Rash  1  5/69 (7.25%)  10 3/65 (4.62%)  4
Vascular disorders     
Flushing  1  4/69 (5.80%)  4 1/65 (1.54%)  1
Hypertension  1  9/69 (13.04%)  10 1/65 (1.54%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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.
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: NCT01427933     History of Changes
Other Study ID Numbers: 14392
I4T-IE-JVCD ( Other Identifier: Eli Lilly and Company )
CP12-1134 ( Other Identifier: Imclone Systems )
First Submitted: August 31, 2011
First Posted: September 2, 2011
Results First Submitted: July 29, 2014
Results First Posted: August 19, 2014
Last Update Posted: February 6, 2017