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

Stopped early · Phase 1

Conditions studied: Gastrointestinal Neoplasms

In brief

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.

Key facts

Study ID

NCT00300027

Run by

Bristol-Myers Squibb

People needed

50

Starts

2006-04-01

Last updated by the study team

2010-03-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Brain metastasis
• Thromboembolic disease
• Cardiovascular disease

Where it is running

• Local Institution — Little Rock, Arkansas, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution — Iowa City, Iowa, United States
• Local Institution — Durham, North Carolina, United States
• Local Institution — Temple, Texas, United States

Full record on ClinicalTrials.gov

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