A Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors
概览
- 阶段
- 1 期
- 干预措施
- Capecitabine
- 疾病 / 适应症
- Advanced Cancer
- 发起方
- Bristol-Myers Squibb
- 入组人数
- 111
- 试验地点
- 4
- 主要终点
- 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
- 状态
- 已完成
- 最后更新
- 10年前
概览
简要总结
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
研究者
入排标准
入选标准
- •Histologic/cytologic diagnosis of advanced or metastatic solid tumors
- •Life expectancy \>= 3 months
- •Able to swallow tablets/capsules
排除标准
- •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
研究组 & 干预措施
Arm A (Capecitabine + Brivanib alaninate)
干预措施: Capecitabine
Arm A (Capecitabine + Brivanib alaninate)
干预措施: Brivanib alaninate
Arm B (Doxorubicin + Brivanib alaninate)
干预措施: Doxorubicin
Arm B (Doxorubicin + Brivanib alaninate)
干预措施: Brivanib alaninate
Arm C (Ixabepilone + Brivanib alaninate)
干预措施: Ixabepilone
Arm C (Ixabepilone + Brivanib alaninate)
干预措施: Brivanib alaninate
Arm D (Docetaxel + Brivanib alaninate)
干预措施: Docetaxel
Arm D (Docetaxel + Brivanib alaninate)
干预措施: Brivanib alaninate
Arm E (Paclitaxel + Brivanib alaninate)
干预措施: Paclitaxel
Arm E (Paclitaxel + Brivanib alaninate)
干预措施: Brivanib alaninate
结局指标
主要结局
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
时间窗: Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached
次要结局
- 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)