A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combinations With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer Preceded By A Phase 1 Portion
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With Objective Response: Phase 2
Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.
Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
A4061020
NCT00460603
January 2006
November 2012
Name | Location |
---|---|
Pfizer Investigational Site | Birmingham, Alabama 35205 |
Pfizer Investigational Site | Blendora, California 91740 |
Pfizer Investigational Site | Atlanta, Georgia 30342 |
Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
Pfizer Investigational Site | Detroit, Michigan 48201 |
Pfizer Investigational Site | Bronx, New York 10461 |
Pfizer Investigational Site | Houston, Texas 77030 |
Pfizer Investigational Site | Federal Way, Washington 98003 |
Pfizer Investigational Site | Aurora, Colorado 80012 |
Pfizer Investigational Site | Clearwater, Florida 33761 |
Pfizer Investigational Site | Carmel, Indiana 46032 |
Pfizer Investigational Site | Kansas City, Kansas 66112 |
Pfizer Investigational Site | Columbia, Missouri 65201 |
Pfizer Investigational Site | Las Vegas, Nevada 89128 |
Pfizer Investigational Site | Asheville, North Carolina 28801 |
Pfizer Investigational Site | Eugene, Oregon 97401 |
Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
Pfizer Investigational Site | Easley,, South Carolina 29640 |
Pfizer Investigational Site | Shreveport, Louisiana 71103 |
Pfizer Investigational Site | Omaha, Nebraska 68198 |
Pfizer Investigational Site | Bristol, Tennessee 37620 |
Pfizer Investigational Site | Livingston, New Jersey 07039 |
Pfizer Investigational Site | Salt Lake City, Utah 84112 |