A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

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

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.

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.