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Brief Title: A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
Official Title: An Open-Label, Multi-Center, Randomized Phase 1b/2 Study Of PF-05212384 Plus 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
Study ID: NCT01937715
Brief Summary: This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI. The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare, Fullerton, California, United States
UCLA Hematology Oncology, Irvine, California, United States
Drug Management Only: UCLA West Medical Pharmacy, Attn Steven L. Wong, Pharm .D., Los Angeles, California, United States
Drug Management Only: UCLA West Medical Pharmacy, Los Angeles, California, United States
UCLA West Medical Pharmacy, Att: Steven L. Wong, Pharm D., Los Angeles, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
Ronald Regan UCLA Medical Center, Drug Information Center, Los Angeles, California, United States
TRIO-US Central Administration, Regulatory Management Only, Los Angeles, California, United States
TRIO-US Central Administration, Los Angeles, California, United States
TRIO_US, Los Angeles, California, United States
UCLA Hematology Oncology Administrative Address, Los Angeles, California, United States
Westwood Bowyer Clinic, Peter Morton Medical Building, Los Angeles, California, United States
West Valley Hematology/Oncology Med Group, Northridge, California, United States
UCLA/Pasadena Healthcare, Pasadena, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
UCLA Hematology Oncology, Santa Monica, California, United States
UCLA Santa Monica Medical Center & Orthopaedic Hospital, Santa Monica, California, United States
UCLA/Santa Clarita Valley Cancer Center, Valencia, California, United States
UCLA Cancer Center, Westlake Village, California, United States
Comprehensive Cancer Centers of Nevada Research Department, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Comprehensive Cancer Centers of NV, Las Vegas, Nevada, United States
COmprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Centers for Nevada, Las Vegas, Nevada, United States
Metrohealth Medical Center, Cleveland, Ohio, United States
Medical Group of the Carolinas - Hematology Spartanburg, Spartanburg, South Carolina, United States
Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Kadlec Medical Center, Richland, Washington, United States
Outpatient Imaging Center, Richland, Washington, United States
Investigational Drug Services, Seattle, Washington, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Spokane Valley Cancer Center, Spokane Valley, Washington, United States
Medical Oncology Associates, PS, Spokane, Washington, United States
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR