A Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors
18 Years
75 Years
Both
Advanced Cancer
Trial Information
A Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA182-030
NCT ID:
NCT00798252
Start Date:
March 2009
Completion Date:
July 2013
Related Keywords:
- Advanced Cancer
- metastatic, chemotherapy combination
- Neoplasms
Name | Location |
|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| Wayne State University | Detroit, Michigan 48202 |
| Dana Faber Cancer Institute | Boston, Massachusetts 02115 |
