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

This study has been completed.
Sponsor:
Collaborator:
ImClone LLC
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01183780
First received: August 4, 2010
Last updated: September 2, 2016
Last verified: September 2016
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 
Overall Participants Analyzed 
[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 FU ]

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01183780     History of Changes
Other Study ID Numbers: 13856
I4T-MC-JVBB ( Other Identifier: Eli Lilly and Company )
CP12-0920 ( Other Identifier: ImClone LLC Trial Number )
2010-021037-32 ( EudraCT Number )
CTRI/2011/07/001900 ( Registry Identifier: Clinical Trials Registry India )
Study First Received: August 4, 2010
Results First Received: June 19, 2015
Last Updated: September 2, 2016
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