Colon Cancer Clinical Trial
A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer
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.
Eligibility Criteria
Inclusion Criteria:
KRAS and NRAS wild type metastatic colorectal cancer
Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
Eastern Cooperative Oncology Group [ECOG] Performance Status of 0, 1, or 2
At least one measurable lesion by Response Evaluation Criterion in Solid Tumors [RECIST]
Exclusion Criteria:
More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
Prior radiation to the pelvis or abdomen
Patients with history of interstitial lung disease.
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There are 25 Locations for this study
Bakersfield California, 93309, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Northridge California, 91328, United States
Creve Coeur Missouri, 63141, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63129, United States
Saint Peters Missouri, 63376, United States
Henderson Nevada, 89014, United States
Henderson Nevada, 89052, United States
Henderson Nevada, 89074, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89169, United States
Buffalo New York, 14263, United States
Kennewick Washington, 99336, United States
Richland Washington, 99352, United States
Richland Washington, 99352, United States
Spokane Valley Washington, 99216, United States
Spokane Washington, 99208, United States
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 277-8, Japan
Goyang-si Gyeonggi-do, 410-7, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Madrid , 28009, Spain
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