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Study With IMC-A12 (Cixutumumab) in Patients Who Have Not Previously Been Treated With Chemotherapy With Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00520481
Recruitment Status : Completed
First Posted : August 24, 2007
Results First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adenocarcinoma of the Prostate
Intervention Drug: IMC-A12 (Cixutumumab)
Enrollment 41

Recruitment Details  
Pre-assignment Details Participants who had results for the primary outcome measures were considered to have completed the study. The primary outcome measure is: Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab.
Arm/Group Title IMC-A12 (Cixutumumab) 10 mg/kg Cixutumumab 20 mg/kg
Hide Arm/Group Description Cixutumumab was administered at 10 milligrams/kilogram (mg/kg) as intravenous (i.v.) infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity. Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
Period Title: Overall Study
Started 31 10
Received at Least 1 Dose of Study Drug 31 10
Completed 24 9
Not Completed 7 1
Reason Not Completed
Adverse Event             4             1
Withdrawal by Subject             3             0
Arm/Group Title Cixutumumab 10 mg/kg Cixutumumab 20 mg /kg Total
Hide Arm/Group Description Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity. Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 31 10 41
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 10 participants 41 participants
70.0  (9.26) 70.2  (6.78) 70.1  (8.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 10 participants 41 participants
Female 0 0 0
Male 31 10 41
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 10 participants 41 participants
Hispanic or Latino 2 0 2
Not Hispanic or Latino 29 10 39
Unknown or Not Reported 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 10 participants 41 participants
White 30 10 40
Hispanic 1 0 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 31 participants 10 participants 41 participants
31 10 41
1.Primary Outcome
Title Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab
Hide Description cTTP was the time from the first day of treatment to the earliest onset of 1 of the following: tumor progression by Response Evaluation Criteria In Solid Tumors [RECIST, version 1.0] criteria: unequivocal evidence of progression by bone scan, new skeletal events, symptomatic progression (for participants without measurable disease), or other clinical events attributable to prostate cancer that in the opinion of the investigator require major interventions. Participants without tumor progression at data cut-off were censored.
Time Frame From first dose of study drug until progressive disease (Up to 49.2 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg =7; or Cixutumumab 20 mg/kg = 2.
Arm/Group Title Cixutumumab 10 mg/kg Cixutumumab 20 mg/kg
Hide Arm/Group Description:
Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
Cixutumumab was administered at or 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
Overall Number of Participants Analyzed 31 10
Median (95% Confidence Interval)
Unit of Measure: months
4.9
(1.9 to 7.0)
3.2
(1.0 to 8.8)
2.Primary Outcome
Title Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks
Hide Description [Not Specified]
Time Frame Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h postdose for Cycle 4; predose and 1 h post dose for Cycles 5 to 9)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as the data were not estimable accurately due to the study sampling schedule.
Arm/Group Title Cixutumumab 20 mg/kg
Hide Arm/Group Description:
Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks
Hide Description [Not Specified]
Time Frame Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h post dose for Cycle 4; predose and 1 h postdose for Cycles 5 to 9)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and had evaluable pharmacokinetic (PK) samples for Cmax on Cycle 1 and Cycle 5.
Arm/Group Title Cixutumumab 20 mg/kg
Hide Arm/Group Description:
Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms/milliliter (µg/ml)
After first dose Number Analyzed 8 participants
993
(20%)
After fifth dose Number Analyzed 4 participants
1780
(53%)
4.Secondary Outcome
Title Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs)
Hide Description Clinically significant events were defined as SAEs and other non-serious adverse events AEs. Participants who died due to progressive disease (PD), AEs while on treatment or died during the 30 day post-treatment are included. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Time Frame From randomization up to 49.2 months (and 30 day follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received any dose of Cixutumumab.
Arm/Group Title Cixutumumab 10 mg/kg Cixutumumab 20 mg/kg
Hide Arm/Group Description:
Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
Overall Number of Participants Analyzed 31 10
Measure Type: Count of Participants
Unit of Measure: Participants
Non-serious AEs 28 10
SAEs 6 0
Deaths due to PD 1 0
Deaths due to AEs 1 0
5.Secondary Outcome
Title Time to Radiographically Evident Disease Progression
Hide Description This is the time between first dose and radiographic progression defined as either: progression of measurable or non measurable lesions using the RECIST v 1.0, evidence of progression by bone scan or new skeletal event including new pathologic bone fracture, new bone lesion requiring radiation or surgery, or spinal cord/nerve root compression. Participants without evidence of disease progression at the date of latest tumor or bone radiograph were censored.
Time Frame From first dose of study drug until radiographic progression (up to 48.6 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg = 9; Cixutumumab 20 mg/kg = 2.
Arm/Group Title Cixutumumab 10 mg/kg Cixutumumab 20 mg/kg
Hide Arm/Group Description:
Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
Overall Number of Participants Analyzed 31 10
Median (95% Confidence Interval)
Unit of Measure: months
4.8
(1.9 to 7.5)
3.3
(1.9 to 8.8)
6.Secondary Outcome
Title Number of Participants With Complete Response (CR) or Partial Response (PR) (Tumor Response Rate)
Hide Description Response was defined using RECIST v1.0 criteria: CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of longest diameter of target lesions
Time Frame From Randomization up to progressive disease (49.2 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.
Arm/Group Title Cixutumumab 10 mg/kg Cixutumumab 20 mg/kg
Hide Arm/Group Description:
Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
Overall Number of Participants Analyzed 31 10
Measure Type: Count of Participants
Unit of Measure: Participants
0 0
7.Secondary Outcome
Title Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate
Hide Description Percentage of participants with a PSA decrease of at least 50% from baseline PSA provided the participant had a PSA value of at least 2 nanograms per milliliter (ng/ml) at baseline. Percentage calculated as: (number of participants with PSA response rate / total number of participants) *100.
Time Frame From Randomization up to 6.21 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.
Arm/Group Title Cixutumumab 10 mg/kg Cixutumumab 20 mg/kg
Hide Arm/Group Description:
Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
Overall Number of Participants Analyzed 31 10
Measure Type: Count of Participants
Unit of Measure: Participants
1.0 0.0
8.Secondary Outcome
Title Progression-Free Survival (PFS) Rate at 6 Months
Hide Description PFS rate was the proportion of participants who had stable disease (SD), PR, or CR and were alive at 6 months after receiving their first dose of study medication. Response was defined using RECIST v1.0 criteria: CR was defined as the disappearance of all target lesions, PR was defined as at least a 30% decrease in sum of longest diameter of target lesions, and SD was defined as shrinkage or increase in tumor size that did not meet the above criteria. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. Percentage of participants = (Number of participants with PFS at 6 months / total number of participants analyzed) *100.
Time Frame From randomization up to 48.6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg - 7; Cixutumumab 20 mg/kg = 2.
Arm/Group Title Cixutumumab 10 mg/kg Cixutumumab 20 mg/kg
Hide Arm/Group Description:
Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
Overall Number of Participants Analyzed 31 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41.1
(22.3 to 59.0)
40.0
(12.3 to 67.0)
9.Secondary Outcome
Title Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks
Hide Description [Not Specified]
Time Frame Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as the data were not estimable accurately due to the study sampling schedule.
Arm/Group Title Cixutumumab 10 mg/kg
Hide Arm/Group Description:
Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks
Hide Description [Not Specified]
Time Frame Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and had evaluable PK samples for Cmax on Cycle 1 only in 10 mg/kg group.
Arm/Group Title Cixutumumab 10 mg/kg
Hide Arm/Group Description:
Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
Overall Number of Participants Analyzed 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/ml
NA [1] 
(NA%)
[1]
Per Clinical Study Report, Cmax was not estimated because of small number of participants with evaluable data (n=2). Individual participant data not provided for data privacy reasons.
Time Frame From Randomization up to 49.2 months (and 30-day follow-up)
Adverse Event Reporting Description Study-specific clinical outcomes due to progressive disease were not considered to be serious adverse events (SAEs) unless it was deemed related to study drug by the investigator.
 
Arm/Group Title Cixutumumab 10 mg/kg Cixutumumab 20 mg/kg
Hide Arm/Group Description Cixutumumab was administered at 10 mg/kg as intravenous (i.v.) infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity. Cixutumumab was administered at 20mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
All-Cause Mortality
Cixutumumab 10 mg/kg Cixutumumab 20 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cixutumumab 10 mg/kg Cixutumumab 20 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/31 (19.35%)      0/10 (0.00%)    
Cardiac disorders     
CARDIAC FAILURE CONGESTIVE  1  1/31 (3.23%)  1 0/10 (0.00%)  0
General disorders     
DISEASE PROGRESSION  1  1/31 (3.23%)  1 0/10 (0.00%)  0
FATIGUE  1  1/31 (3.23%)  1 0/10 (0.00%)  0
Infections and infestations     
PNEUMONIA  1  1/31 (3.23%)  1 0/10 (0.00%)  0
Investigations     
TROPONIN I INCREASED  1  1/31 (3.23%)  1 0/10 (0.00%)  0
Metabolism and nutrition disorders     
DEHYDRATION  1  1/31 (3.23%)  1 0/10 (0.00%)  0
FAILURE TO THRIVE  1  1/31 (3.23%)  1 0/10 (0.00%)  0
HYPERGLYCAEMIA  1  2/31 (6.45%)  2 0/10 (0.00%)  0
HYPOGLYCAEMIA  1  1/31 (3.23%)  1 0/10 (0.00%)  0
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  1  1/31 (3.23%)  1 0/10 (0.00%)  0
LEUKOENCEPHALOPATHY  1  1/31 (3.23%)  1 0/10 (0.00%)  0
Renal and urinary disorders     
RENAL FAILURE  1  2/31 (6.45%)  2 0/10 (0.00%)  0
Vascular disorders     
VERTEBRAL ARTERY OCCLUSION  1  1/31 (3.23%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cixutumumab 10 mg/kg Cixutumumab 20 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/31 (90.32%)      10/10 (100.00%)    
Blood and lymphatic system disorders     
LEUKOCYTOSIS  1  0/31 (0.00%)  0 1/10 (10.00%)  1
Cardiac disorders     
ANGINA PECTORIS  1  0/31 (0.00%)  0 2/10 (20.00%)  2
CORONARY ARTERY DISEASE  1  0/31 (0.00%)  0 1/10 (10.00%)  1
OEDEMA PERIPHERAL  1  0/31 (0.00%)  0 1/10 (10.00%)  1
Ear and labyrinth disorders     
EAR DISORDER  1  2/31 (6.45%)  2 0/10 (0.00%)  0
VERTIGO  1  2/31 (6.45%)  2 0/10 (0.00%)  0
Eye disorders     
EYELID OEDEMA  1  0/31 (0.00%)  0 1/10 (10.00%)  1
VISUAL DISTURBANCE  1  5/31 (16.13%)  7 1/10 (10.00%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN  1  2/31 (6.45%)  2 0/10 (0.00%)  0
CONSTIPATION  1  5/31 (16.13%)  5 1/10 (10.00%)  1
DIARRHOEA  1  5/31 (16.13%)  5 2/10 (20.00%)  2
DRY MOUTH  1  3/31 (9.68%)  3 0/10 (0.00%)  0
DYSGEUSIA  1  4/31 (12.90%)  4 0/10 (0.00%)  0
NAUSEA  1  11/31 (35.48%)  15 2/10 (20.00%)  2
VOMITING  1  5/31 (16.13%)  7 1/10 (10.00%)  1
General disorders     
ASTHENIA  1  1/31 (3.23%)  1 1/10 (10.00%)  1
CHILLS  1  0/31 (0.00%)  0 1/10 (10.00%)  1
FATIGUE  1  12/31 (38.71%)  20 4/10 (40.00%)  5
INFUSION RELATED REACTION  1  3/31 (9.68%)  4 2/10 (20.00%)  3
PYREXIA  1  1/31 (3.23%)  1 1/10 (10.00%)  2
Immune system disorders     
HYPERSENSITIVITY  1  0/31 (0.00%)  0 1/10 (10.00%)  1
Infections and infestations     
NAIL INFECTION  1  0/31 (0.00%)  0 1/10 (10.00%)  1
SINUSITIS  1  3/31 (9.68%)  3 0/10 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  4/31 (12.90%)  5 2/10 (20.00%)  2
URINARY TRACT INFECTION  1  0/31 (0.00%)  0 1/10 (10.00%)  2
Investigations     
WEIGHT DECREASED  1  12/31 (38.71%)  18 2/10 (20.00%)  3
Metabolism and nutrition disorders     
ANOREXIA  1  5/31 (16.13%)  5 0/10 (0.00%)  0
DECREASED APPETITE  1  0/31 (0.00%)  0 1/10 (10.00%)  1
DEHYDRATION  1  0/31 (0.00%)  0 1/10 (10.00%)  1
DIABETES MELLITUS  1  2/31 (6.45%)  3 1/10 (10.00%)  1
HYPERGLYCAEMIA  1  6/31 (19.35%)  9 2/10 (20.00%)  3
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  5/31 (16.13%)  9 1/10 (10.00%)  2
BONE PAIN  1  9/31 (29.03%)  10 2/10 (20.00%)  5
GROIN PAIN  1  3/31 (9.68%)  5 0/10 (0.00%)  0
JOINT SWELLING  1  0/31 (0.00%)  0 1/10 (10.00%)  3
MUSCLE SPASMS  1  1/31 (3.23%)  1 3/10 (30.00%)  3
MUSCULAR WEAKNESS  1  0/31 (0.00%)  0 1/10 (10.00%)  1
MUSCULOSKELETAL DISCOMFORT  1  0/31 (0.00%)  0 1/10 (10.00%)  2
MYALGIA  1  0/31 (0.00%)  0 1/10 (10.00%)  1
NECK PAIN  1  0/31 (0.00%)  0 1/10 (10.00%)  1
SHOULDER PAIN  1  2/31 (6.45%)  2 0/10 (0.00%)  0
Nervous system disorders     
BALANCE DISORDER  1  0/31 (0.00%)  0 1/10 (10.00%)  1
DIZZINESS  1  2/31 (6.45%)  2 1/10 (10.00%)  1
DYSPHONIA  1  0/31 (0.00%)  0 1/10 (10.00%)  1
HEADACHE  1  1/31 (3.23%)  1 1/10 (10.00%)  1
HYPOAESTHESIA  1  2/31 (6.45%)  2 0/10 (0.00%)  0
INSOMNIA  1  2/31 (6.45%)  2 0/10 (0.00%)  0
TREMOR  1  0/31 (0.00%)  0 1/10 (10.00%)  1
Psychiatric disorders     
ANXIETY  1  0/31 (0.00%)  0 1/10 (10.00%)  1
Renal and urinary disorders     
HAEMATURIA  1  1/31 (3.23%)  1 1/10 (10.00%)  1
PROTEINURIA  1  1/31 (3.23%)  1 1/10 (10.00%)  1
URINARY INCONTINENCE  1  0/31 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
COUGH  1  2/31 (6.45%)  2 0/10 (0.00%)  0
DYSPNOEA  1  1/31 (3.23%)  1 2/10 (20.00%)  2
Skin and subcutaneous tissue disorders     
DERMATITIS ALLERGIC  1  0/31 (0.00%)  0 1/10 (10.00%)  1
ERYTHEMA OF EYELID  1  0/31 (0.00%)  0 1/10 (10.00%)  1
NAIL DISORDER  1  3/31 (9.68%)  5 0/10 (0.00%)  0
PRURITUS  1  2/31 (6.45%)  2 0/10 (0.00%)  0
RASH  1  3/31 (9.68%)  4 0/10 (0.00%)  0
Vascular disorders     
EPISTAXIS  1  2/31 (6.45%)  2 0/10 (0.00%)  0
HYPOTENSION  1  1/31 (3.23%)  1 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
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: NCT00520481     History of Changes
Other Study ID Numbers: 13934
CP13-0603 ( Other Identifier: ImClone Systems )
I5A-IE-JAEJ ( Other Identifier: Eli Lilly and Company )
First Submitted: August 22, 2007
First Posted: August 24, 2007
Results First Submitted: March 17, 2018
Results First Posted: July 19, 2018
Last Update Posted: July 19, 2018