Study of BMS-582664 in Combination With Either FOLFIRI or FOLFOX for Gastrointestinal (GI) Malignancies
Phase 1
Terminated
- Conditions
- Gastrointestinal Neoplasms
- Registration Number
- NCT00300027
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw) Echocardiogram every 2 cycles (q 2 cycles)
- Secondary Outcome Measures
Name Time Method Tumor response (q 2 cycles) PK parameters (during 1st cycle) PD markers (weekly) Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3)
Trial Locations
- Locations (1)
Local Institution
🇺🇸Temple, Texas, United States
Local Institution🇺🇸Temple, Texas, United States