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 |
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Condition | Advanced Cancer |
Intervention | Drug: Capecitabine Drug: Doxorubicin Drug: Ixabepilone Drug: Docetaxel Drug: Paclitaxel Drug: Brivanib alaninate |
Phase | Phase 1 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00798252 |
First Received | November 25, 2008 |
Last Updated | February 12, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | November 25, 2008 |
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Last Updated Date | February 12, 2014 |
Start Date | March 2009 |
Estimated Primary Completion Date | March 2014 |
Current Primary Outcome Measures | 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] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers |
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Official Title | A 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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Advanced Cancer |
Intervention | 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: 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:
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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 189 |
Estimated Completion Date | March 2014 |
Estimated Primary Completion Date | March 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00798252 |
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Other Study ID Numbers | CA182-030 |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Not Provided |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
Usc/Norris Comprehensive Cancer Center | Los Angeles, California, United States, 90033 |
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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 |