A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors
Phase 1
18 Years
65 Years
18 Years
65 Years
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors
Inclusion Criteria:
- Patients eligible for FOLFIRI or FOLFOX therapy
- ECOG performance status score 0-1
- At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
- At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance
tamoxifen or Tarceva)
- No maximum age for Study Arm A (FOLFOX)
- 18-65 years of age for Study Arm B (FOLFIRI)
Exclusion Criteria:
- Treatment with other TKIs within the past 4 weeks
- Active inflammatory bowel disease
- Major gastrointestinal surgery which may affect absorption of the drug, any surgery
within the last 4 weeks
- History of thromboembolism
- Severe unmanageable diarrhea
- Uncontrolled or significant cardiovascular disease
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety assessment
Outcome Time Frame:
throughout the study
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA187-005
NCT ID:
NCT00479583
Start Date:
September 2007
Completion Date:
April 2010
Related Keywords:
- Cancer
- Cancer (solid tumors)
Name | Location |
|---|---|
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
