Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX
- Registration Number
- NCT00479583
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A BMS-690514 / FOLFIRI - B BMS-690514 / FOLFOX -
- Primary Outcome Measures
Name Time Method Safety assessment throughout the study dose-limiting toxicity (DLT) assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified determination of maximum tolerated dose (MTD) during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
- Secondary Outcome Measures
Name Time Method Describe anti-tumor of combination therapy Every 8 weeks throughout the study Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples throughtout the study
Trial Locations
- Locations (3)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Local Institution
🇫🇷Villejuif, France