Study of BMS-582664 in Combination With Either FOLFIRI or FOLFOX for Gastrointestinal (GI) Malignancies

A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Combination With 5-Fluorouracil/Leucovorin and Irinotecan or Oxaliplatin for Patients With Advanced or Metastatic Cancer

The purpose of this study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced gastrointestinal malignancies and to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.

Inclusion Criteria:

• Good performance status
• Advanced colorectal, pancreatic, esophageal or gastric cancer
• Tissue for analyses
• Adequate bone marrow, hepatic, renal function
• 4-6 weeks since prior therapy
• Adequate protection for women of child bearing potential (WOCBP)

Exclusion Criteria:

• Brain metastasis
• Thromboembolic disease
• Cardiovascular disease