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Completed

NCT Number: NCT00798252

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

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

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Key information

Conditions

Advanced Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

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®

Doxorubicin

Drug

IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression

Other names: Adriamycin®

ixabepilone

Drug

IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression

Other names: IXEMPRA®, BMS-247550

docetaxel

Drug

IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression

Other names: Taxotere®

paclitaxel

Drug

IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression

Other names: Taxol®

Brivanib Alaninate

Drug

Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression

Other names: BMS-540215

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Nov 26, 2008
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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