Gastrointestinal Neoplasms
Conditions
Keywords
Advanced Gastrointestinal Malignancies
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.
Interventions
DRUGBMS-582664
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw) | — |
| Echocardiogram every 2 cycles (q 2 cycles) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response (q 2 cycles) | — |
| PK parameters (during 1st cycle) | — |
| PD markers (weekly) | — |
| Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3) | — |
Countries
United States
Outcome results
None listed