A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen
Participants were
- randomized at baseline (treatment was initiated with 3 days of randomization)
- administered treatment in cycles of 14-days till a study withdrawal criterion was met
- followed up 30 days after discontinuation of treatment, and every 8 weeks until death
or end of study.
The criteria for discontinuation of study treatment for a participant are:
- participant (or legal representative) chose to withdraw from treatment
- the investigator thought that continuation of the study would be detrimental to the
participants well-being due to
- disease progression
- unacceptable AEs
- intercurrent illnesses
- non-compliance to the study protocol
- participant was lost to follow-up
- participant was unblinded for the investigational treatment
Participants who met the following main selection criteria were included in the study.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Overall Survival (OS)
Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.
From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
EFC10262
NCT00561470
November 2007
June 2012
Name | Location |
---|---|
Sanofi-Aventis Investigational Site Number 840010 | Chicago, Illinois 60611 |
Sanofi-Aventis Investigational Site Number 840046 | Los Angeles, California 90033 |
Sanofi-Aventis Investigational Site Number 840001 | Oceanside, California 92056 |
Sanofi-Aventis Investigational Site Number 840026 | High Point, North Carolina 27262 |
Sanofi-Aventis Investigational Site Number 840006 | San Diego, California 92103 |
Sanofi-Aventis Investigational Site Number 840119 | Birmingham, Alabama 35203 |
Sanofi-Aventis Investigational Site Number 840074 | Muscle Shoals, Alabama 35661 |
Sanofi-Aventis Investigational Site Number 840093 | Hot Springs, Arizona 71913 |
Sanofi-Aventis Investigational Site Number 840080 | Anaheim, California 92801 |
Sanofi-Aventis Investigational Site Number 840076 | Fountain Valley, California 92708 |
Sanofi-Aventis Investigational Site Number 840120 | Fountain Valley, California 92708 |
Sanofi-Aventis Investigational Site Number 840073 | Greenbrae, California 94904-2007 |
Sanofi-Aventis Investigational Site Number 840101 | Hayward, California 94545 |
Sanofi-Aventis Investigational Site Number 840116 | Loma Linda, California 92354 |
Sanofi-Aventis Investigational Site Number 840048 | Long Beach, California 90813 |
Sanofi-Aventis Investigational Site Number 840201 | Oakland, California 94611 |
Sanofi-Aventis Investigational Site Number 840901 | Roseville, California 95678 |
Sanofi-Aventis Investigational Site Number 840301 | Sacramento, California 95825 |
Sanofi-Aventis Investigational Site Number 840042 | Sacramento, California 95816 |
Sanofi-Aventis Investigational Site Number 840112 | Salinas, California 93901-3906 |
Sanofi-Aventis Investigational Site Number 840406 | San Diego, California 92102 |
Sanofi-Aventis Investigational Site Number 840506 | San Diego, California 92102 |
Sanofi-Aventis Investigational Site Number 840606 | San Diego, California 92102 |
Sanofi-Aventis Investigational Site Number 840806 | San Diego, California 92102 |
Sanofi-Aventis Investigational Site Number 840906 | San Diego, California 92102 |
Sanofi-Aventis Investigational Site Number 840306 | San Diego, California 92102 |
Sanofi-Aventis Investigational Site Number 840706 | San Diego, California 92102 |
Sanofi-Aventis Investigational Site Number 840106 | San Diego, California 92102 |
Sanofi-Aventis Investigational Site Number 840206 | San Diego, California 92102 |
Sanofi-Aventis Investigational Site Number 840401 | San Francisco, California 94115 |
Sanofi-Aventis Investigational Site Number 840601 | San Jose, California 95119 |
Sanofi-Aventis Investigational Site Number 840501 | Santa Clara, California 95051 |
Sanofi-Aventis Investigational Site Number 840801 | South San Francisco, California 94080 |
Sanofi-Aventis Investigational Site Number 840701 | Walnut Creek, California 94596 |
Sanofi-Aventis Investigational Site Number 840071 | Stamford, Connecticut 06902 |
Sanofi-Aventis Investigational Site Number 840014 | Newark, Delaware 19718 |
Sanofi-Aventis Investigational Site Number 840089 | Boynton Beach, Florida 33435 |
Sanofi-Aventis Investigational Site Number 840031 | Gainesville, Florida 32610 |
Sanofi-Aventis Investigational Site Number 840041 | Gainesville, Florida 32608 |
Sanofi-Aventis Investigational Site Number 840122 | Miami, Florida 33176 |
Sanofi-Aventis Investigational Site Number 840079 | The Villages, Florida 32159 |
Sanofi-Aventis Investigational Site Number 840087 | Chicago, Illinois 60616 |
Sanofi-Aventis Investigational Site Number 840019 | Decatur, Illinois 62526 |
Sanofi-Aventis Investigational Site Number 840115 | Elk Grove Village, Illinois 60007 |
Sanofi-Aventis Investigational Site Number 840113 | Quincy, Illinois 62301 |
Sanofi-Aventis Investigational Site Number 840072 | Indianapolis, Indiana 46254 |
Sanofi-Aventis Investigational Site Number 840047 | Indianapolis, Indiana 46260 |
Sanofi-Aventis Investigational Site Number 840034 | Munster, Indiana 46321 |
Sanofi-Aventis Investigational Site Number 840088 | Louisville, Kentucky 40202 |
Sanofi-Aventis Investigational Site Number 840096 | Paducah, Kentucky 42003 |
Sanofi-Aventis Investigational Site Number 840043 | Baton Rouge, Louisiana 70809 |
Sanofi-Aventis Investigational Site Number 840084 | Metairie, Louisiana 70006 |
Sanofi-Aventis Investigational Site Number 840015 | New Orleans, Louisiana 70121 |
Sanofi-Aventis Investigational Site Number 840070 | Rockville, Maryland 20850 |
Sanofi-Aventis Investigational Site Number 840029 | Salisbury, Maryland 21801 |
Sanofi-Aventis Investigational Site Number 840053 | Pontiac, Michigan 48341 |
Sanofi-Aventis Investigational Site Number 840021 | St Louis Park, Minnesota 55416 |
Sanofi-Aventis Investigational Site Number 840081 | Kansas City, Missouri 64128 |
Sanofi-Aventis Investigational Site Number 840052 | St Louis, Missouri 63104 |
Sanofi-Aventis Investigational Site Number 840114 | St. Louis, Missouri 63136 |
Sanofi-Aventis Investigational Site Number 840049 | Las Vegas, Nevada 89106 |
Sanofi-Aventis Investigational Site Number 840044 | Albuquerque, New Mexico 87131 |
Sanofi-Aventis Investigational Site Number 840036 | Albany, New York 12206 |
Sanofi-Aventis Investigational Site Number 840094 | Lake Success, New York 11042 |
Sanofi-Aventis Investigational Site Number 840097 | Syracuse, New York 13210 |
Sanofi-Aventis Investigational Site Number 840017 | Syracuse, New York 13210 |
Sanofi-Aventis Investigational Site Number 840035 | Burlington, North Carolina 27215 |
Sanofi-Aventis Investigational Site Number 840024 | Charlotte, North Carolina 28204 |
Sanofi-Aventis Investigational Site Number 840005 | Goldsboro, North Carolina 27534 |
Sanofi-Aventis Investigational Site Number 840004 | Hendersonville, North Carolina 28791 |
Sanofi-Aventis Investigational Site Number 840075 | Winston-Salem, North Carolina 27103 |
Sanofi-Aventis Investigational Site Number 840098 | Cincinnati, Ohio 45219 |
Sanofi-Aventis Investigational Site Number 840011 | Kettering, Ohio 45429 |
Sanofi-Aventis Investigational Site Number 840086 | Middletown, Ohio 45042 |
Sanofi-Aventis Investigational Site Number 840008 | Toledo, Ohio 43623 |
Sanofi-Aventis Investigational Site Number 840039 | Portland, Oregon 97227 |
Sanofi-Aventis Investigational Site Number 840118 | Bethlehem, Pennsylvania 18015 |
Sanofi-Aventis Investigational Site Number 840033 | Philadelphia, Pennsylvania 19107 |
Sanofi-Aventis Investigational Site Number 840012 | Pittsburgh, Pennsylvania 15212 |
Sanofi-Aventis Investigational Site Number 840082 | Pawtucket, Rhode Island 02860 |
Sanofi-Aventis Investigational Site Number 840095 | Woonsocket, Rhode Island 02895 |
Sanofi-Aventis Investigational Site Number 840085 | Charleston, South Carolina 29403 |
Sanofi-Aventis Investigational Site Number 840037 | Spartanburg, South Carolina 29303 |
Sanofi-Aventis Investigational Site Number 840078 | Corpus Christi, Texas 78405 |
Sanofi-Aventis Investigational Site Number 840117 | Temple, Texas 76508 |
Sanofi-Aventis Investigational Site Number 840099 | Seattle, Washington 98115 |
Sanofi-Aventis Investigational Site Number 840002 | Marshfield, Wisconsin 54449 |