Conditions: Metastatic Colorectal Cancer
Keywords: metastatic colorectal cancer colorectal cancer KRAS colon cancer mCRC CRC PF-05212384 KRAS wild type colorectal cancer irinotecan cetuximab NRAS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 19
Healthy volunteers: no

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:

Arms:
arm 1: PF-05212384 plus Irinotecan arm 2: Cetuximab plus Irinotecan

Interventions: intervention 1: PF-05212384 intervention 2: irinotecan intervention 3: Cetuximab intervention 4: Irinotecan
Intervention descriptions: intervention 1: 30 minute IV infusion of PF-05212384 on days 2, 9, 16 and 23 of each cycle. Intra-patient dose escalation will commence with 110mg and will increase depending on tolerability. intervention 2: 90 minutes IV infusion of irinotecan 180mg/m\^2 on days 1 and 15 of each cycle intervention 3: 120 minute IV infusion of cetuximab 400mg/m\^2 on cycle 1 day 1; 60 minute IV infusion of cetuximab on days 8, 15, and 22 of each cycle, and on day 1 of each cycle after cycle 1 intervention 4: 90 minutes IV infusion of Irinotecan 180mg/m\^2 on days 1 and 15 of each cycle

Protocol document: