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临床试验/NCT00798252
NCT00798252
已完成
1 期

A Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors

Bristol-Myers Squibb4 个研究点 分布在 2 个国家目标入组 111 人2009年3月

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

注册库
clinicaltrials.gov
开始日期
2009年3月
结束日期
2015年5月
最后更新
10年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

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)

研究点 (4)

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