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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Gastrointestinal Neoplasms

Treatments: Drug: BMS-582664

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300027

CA182-007

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)