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Brief Title: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer
Official Title: A RANDOMIZED PHASE 2 STUDY OF PF-05212384 PLUS IRINOTECAN VERSUS CETUXIMAB PLUS IRINOTECAN IN PATIENTS WITH KRAS AND NRAS WILD TYPE METASTATIC COLORECTAL CANCER
Study ID: NCT01925274
Brief Summary: This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Drug Management Only: UCLA West Medical Pharmacy, Att: 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, Los Angeles, California, United States
Regulatory Management Only: TRIO-US Central Administration, Los Angeles, California, United States
TRIO-US Central Administration (Regulatory Management only), Los Angeles, California, United States
TRIO_US, Los Angeles, California, United States
West Valley Hematology/Oncology Med Group, Northridge, California, United States
Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center - South County, Saint Louis, Missouri, United States
Siteman Cancer Center - St Peters, Saint Peters, Missouri, United States
Regulatory Office: Comprehensive Cancer Centers of Nevada, 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 Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Roswell Park Cancer Institute, Buffalo, New York, 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
Spokane Valley Cancer Center, Spokane Valley, Washington, United States
Medical Oncology Associates, PS, Spokane, Washington, United States
Aichi cancer center central hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital / Department of Internal Medicine, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR