Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers
Phase 1
Completed
- Conditions
- Advanced Cancer
- Interventions
- Registration Number
- NCT00798252
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To determine safety and maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
Inclusion Criteria
- Histologic/cytologic diagnosis of advanced or metastatic solid tumors
- Life expectancy >= 3 months
- Able to swallow tablets/capsules
Exclusion Criteria
- Pregnant or breastfeeding women
- No more than 4 previous chemotherapy regimens in the advanced or metastatic setting (excluding prior adjuvant or hormonal / immuno / biologic antibody therapies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B (Doxorubicin + Brivanib alaninate) Brivanib alaninate - Arm A (Capecitabine + Brivanib alaninate) Capecitabine - Arm A (Capecitabine + Brivanib alaninate) Brivanib alaninate - Arm B (Doxorubicin + Brivanib alaninate) Doxorubicin - Arm C (Ixabepilone + Brivanib alaninate) Ixabepilone - Arm D (Docetaxel + Brivanib alaninate) Docetaxel - Arm E (Paclitaxel + Brivanib alaninate) Paclitaxel - Arm E (Paclitaxel + Brivanib alaninate) Brivanib alaninate - Arm C (Ixabepilone + Brivanib alaninate) Brivanib alaninate - Arm D (Docetaxel + Brivanib alaninate) Brivanib alaninate -
- Primary Outcome Measures
Name Time Method To determine safety and the maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached
- Secondary Outcome Measures
Name Time Method To describe the anti-tumor activity of brivanib alaninate combination with the different chemotherapeutic regimens: capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel Every 21 days To assess the effect each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel on the pharmacokinetics of BMS-540215 (active moiety of brivanib pro-drug) at the MTD Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2 To assess the effect of brivanib alaninate on the pharmacokinetics each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel chemotherapy regimens at the MTD Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2
Trial Locations
- Locations (4)
Local Institution
🇨🇦Toronto, Ontario, Canada
Usc/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Wayne State University
🇺🇸Detroit, Michigan, United States