A Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Capecitabine
- Conditions
- Advanced Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 111
- Locations
- 4
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm A (Capecitabine + Brivanib alaninate)
Intervention: Capecitabine
Arm A (Capecitabine + Brivanib alaninate)
Intervention: Brivanib alaninate
Arm B (Doxorubicin + Brivanib alaninate)
Intervention: Doxorubicin
Arm B (Doxorubicin + Brivanib alaninate)
Intervention: Brivanib alaninate
Arm C (Ixabepilone + Brivanib alaninate)
Intervention: Ixabepilone
Arm C (Ixabepilone + Brivanib alaninate)
Intervention: Brivanib alaninate
Arm D (Docetaxel + Brivanib alaninate)
Intervention: Docetaxel
Arm D (Docetaxel + Brivanib alaninate)
Intervention: Brivanib alaninate
Arm E (Paclitaxel + Brivanib alaninate)
Intervention: Paclitaxel
Arm E (Paclitaxel + Brivanib alaninate)
Intervention: Brivanib alaninate
Outcomes
Primary Outcomes
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
Time Frame: Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached
Secondary Outcomes
- 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)