Conditions: Metastatic Colorectal Carcinoma
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 18
Healthy volunteers: no

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:

Arms:
arm 1: PF-05212384 plus FOLFIRI arm 2: Bevacizumab plus FOLFIRI

Interventions: intervention 1: PF-05212384 intervention 2: FOLFIRI regimen intervention 3: Bevacizumab intervention 4: FOLFIRI
Intervention descriptions: intervention 1: PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly intervention 2: The RP2D/MTD dose of FOLFIRI regimen every 2 weeks intervention 3: 5 mg/m\^2 every 2 weeks or 7.5 mg/m\^2 every 3 weeks intervention 4: Full dose FOLFIRI regimen every 2 weeks

Protocol document: