A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer

Inclusion Criteria:

- ECOG Performance Status (PS) ≤1

- Histologically or cytologically confirmed, unresectable metastatic colorectal cancer

- Measurable disease by RECIST guidelines

- Evidence of disease progression following first-line therapy with a fluoropyrimidine,
oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)

- Available paraffin embedded tumor tissue

- Willing to give a whole blood sample for the study of proteins and genetic
polymorphisms

Exclusion Criteria:

- Less than 28 days elapsed since major surgery at time of randomization

- Known CNS metastases

- Excessive risk of bleeding (including use of therapeutic anticoagulation other than
low dose aspirin) and history of thrombotic or embolic cerebrovascular accident

- Uncontrolled hypertension

- Clinically significant cardiovascular disease

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 6 months

- Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or
bleeding skin metastasis

- Known HIV Positive