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

Overview[ - collapse ][ - ]

Purpose 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
ConditionAdvanced Cancer
InterventionDrug: Capecitabine
Drug: Doxorubicin
Drug: Ixabepilone
Drug: Docetaxel
Drug: Paclitaxel
Drug: Brivanib alaninate
PhasePhase 1
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT00798252
First ReceivedNovember 25, 2008
Last UpdatedFebruary 12, 2014
Last verifiedFebruary 2014

Tracking Information[ + expand ][ + ]

First Received DateNovember 25, 2008
Last Updated DateFebruary 12, 2014
Start DateMarch 2009
Estimated Primary Completion DateMarch 2014
Current Primary Outcome MeasuresTo 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] [Designated as safety issue: Yes]
Current Secondary Outcome Measures
  • 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] [Designated as safety issue: Yes]
  • 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] [Designated as safety issue: Yes]
  • 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] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleAscending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers
Official TitleA Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors
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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionAdvanced Cancer
InterventionDrug: 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: Doxorubicin
IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression
Other Names:
Adriamycin®Drug: Ixabepilone
IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression
Other Names:
  • IXEMPRA®
  • BMS-247550
Drug: Docetaxel
IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression
Other Names:
Taxotere®Drug: Paclitaxel
IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression
Other Names:
Taxol®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
Study Arm (s)
  • Experimental: Arm A (Capecitabine + Brivanib alaninate)
  • Experimental: Arm B (Doxorubicin + Brivanib alaninate)
  • Experimental: Arm C (Ixabepilone + Brivanib alaninate)
  • Experimental: Arm D (Docetaxel + Brivanib alaninate)
  • Experimental: Arm E (Paclitaxel + Brivanib alaninate)

Recruitment Information[ + expand ][ + ]

Recruitment StatusActive, not recruiting
Estimated Enrollment189
Estimated Completion DateMarch 2014
Estimated Primary Completion DateMarch 2014
Eligibility Criteria
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Canada

Administrative Information[ + expand ][ + ]

NCT Number NCT00798252
Other Study ID NumbersCA182-030
Has Data Monitoring CommitteeNo
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsNot Provided
Investigators Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification DateFebruary 2014

Locations[ + expand ][ + ]

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