Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers

July 3, 2015 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (Capecitabine + Brivanib alaninate)
Drug: Capecitabine
Tablets, Oral, Dose escalation to a MTD from a starting dose of 850 mg/m², twice a day (BID) x 14d per cycle, until disease progression
Other Names:
  • Xleoda®
Drug: Brivanib alaninate
Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression
Other Names:
  • BMS-540215
Experimental: Arm B (Doxorubicin + Brivanib alaninate)
Drug: Brivanib alaninate
Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression
Other Names:
  • BMS-540215
Drug: Doxorubicin
IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression
Other Names:
  • Adriamycin®
Experimental: Arm C (Ixabepilone + Brivanib alaninate)
Drug: Brivanib alaninate
Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression
Other Names:
  • BMS-540215
Drug: Ixabepilone
IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression
Other Names:
  • BMS-247550
  • IXEMPRA®
Experimental: Arm D (Docetaxel + Brivanib alaninate)
Drug: Brivanib alaninate
Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression
Other Names:
  • BMS-540215
Drug: Docetaxel
IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression
Other Names:
  • Taxotere®
Experimental: Arm E (Paclitaxel + Brivanib alaninate)
Drug: Brivanib alaninate
Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression
Other Names:
  • BMS-540215
Drug: Paclitaxel
IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression
Other Names:
  • Taxol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe the anti-tumor activity of brivanib alaninate combination with the different chemotherapeutic regimens: capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel
Time Frame: Every 21 days
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
Time Frame: Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2
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
Time Frame: Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2
Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 3, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA182-030
  • 2007-005097-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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