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
Phase 1
18 Years
65 Years
18 Years
65 Years
Not Enrolling
Both
Gastrointestinal Neoplasms
Both
Gastrointestinal Neoplasms
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
Authority:
United States: Food and Drug Administration
Study ID:
CA182-007
NCT ID:
NCT00300027
Start Date:
April 2006
Completion Date:
Related Keywords:
- Gastrointestinal Neoplasms
- Advanced Gastrointestinal Malignancies
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
Name | Location |
|---|---|
| Local Institution | Corona, California |
| Local Institution | Washington, District of Columbia |
| Local Institution | Wilmington, North Carolina |
| Local Institution | Austin, Texas |
| Local Institution | Little Rock, Arkansas |
| Local Institution | Iowa City, Iowa |
