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Clinical Trials/NCT00798252
NCT00798252
Completed
Phase 1

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

Bristol-Myers Squibb4 sites in 2 countries111 target enrollmentMarch 2009

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

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (4)

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