Trial record 1 of 1 for:    NCT01183780
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A Study in Second Line Metastatic Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ImClone LLC
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01183780
First received: August 4, 2010
Last updated: June 19, 2015
Last verified: June 2015
Results First Received: June 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Biological: Ramucirumab
Biological: Placebo
Drug: Irinotecan
Drug: Folinic Acid
Drug: 5-Fluorouracil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.

Reporting Groups
  Description
Ramucirumab + FOLFIRI

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil (FOLFIRI). Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 milligrams/kilogram (mg/kg) administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Placebo + FOLFIRI

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.


Participant Flow:   Overall Study
    Ramucirumab + FOLFIRI     Placebo + FOLFIRI  
STARTED     536     536  
Received at Least 1 Dose of Study Drug     528     529  
COMPLETED     493     496  
NOT COMPLETED     43     40  
Withdrawal by Subject                 20                 13  
Lost to Follow-up                 6                 11  
On treatment                 17                 16  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants.

Reporting Groups
  Description
Ramucirumab + FOLFIRI

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 mg/kg administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Placebo + FOLFIRI

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Total Total of all reporting groups

Baseline Measures
    Ramucirumab + FOLFIRI     Placebo + FOLFIRI     Total  
Number of Participants  
[units: participants]
  536     536     1072  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     324     321     645  
>=65 years     212     215     427  
Age  
[units: years]
Median (Full Range)
  62.0   (21.0 to 83.0)     62.0   (33.0 to 87.0)     62.0   (21.0 to 87.0)  
Gender  
[units: participants]
     
Female     247     210     457  
Male     289     326     615  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     38     39     77  
Not Hispanic or Latino     248     221     469  
Unknown or Not Reported     250     276     526  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     111     103     214  
Native Hawaiian or Other Pacific Islander     1     1     2  
Black or African American     14     16     30  
White     405     410     815  
More than one race     3     0     3  
Unknown or Not Reported     2     5     7  
Region of Enrollment  
[units: participants]
     
United States     141     142     283  
Portugal     2     2     4  
Taiwan     5     6     11  
Greece     8     8     16  
Spain     51     60     111  
Israel     7     7     14  
Italy     17     20     37  
India     1     2     3  
France     12     15     27  
Puerto Rico     2     1     3  
Australia     16     19     35  
Denmark     3     8     11  
Netherlands     9     5     14  
Korea, Republic of     22     25     47  
Finland     9     3     12  
Austria     6     12     18  
Czech Republic     40     37     77  
Hungary     24     23     47  
Argentina     7     11     18  
Belgium     30     22     52  
Brazil     2     3     5  
Romania     19     14     33  
Germany     19     25     44  
Japan     74     62     136  
Sweden     10     4     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Randomization to date of death from any cause up to 39.36 months ]

2.  Secondary:   Progression-free Survival (PFS) Time   [ Time Frame: Randomization to measured PD or date of death from any cause up to 38.01 months ]

3.  Secondary:   Percentage of Participants Achieving an Objective Response (Objective Response Rate)   [ Time Frame: Randomization until disease progression up to 38.01 months ]

4.  Secondary:   Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status   [ Time Frame: Baseline up to 171 Weeks ]

5.  Secondary:   Change From Baseline in EuroQol- 5D (EQ-5D)   [ Time Frame: Baseline and 30-day follow-up (FU) up to 171 weeks ]

6.  Secondary:   Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies   [ Time Frame: Cycles 1, 3, 5, and 30-day follow-up ]

7.  Secondary:   Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab   [ Time Frame: Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01183780     History of Changes
Other Study ID Numbers: 13856, I4T-MC-JVBB, CP12-0920, 2010-021037-32, CTRI/2011/07/001900
Study First Received: August 4, 2010
Results First Received: June 19, 2015
Last Updated: June 19, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Ministry of Social Affairs, Public Health and the Environment
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Portugal: National Pharmacy and Medicines Institute
Portugal: Ethics Committee for Clinical Research
Romania: National Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Taiwan: Department of Health
United States: Food and Drug Administration