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


Phase 1
18 Years
75 Years
Open (Enrolling)
Both
Advanced Cancer

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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 CenterLos Angeles, California  90033-0800
Wayne State UniversityDetroit, Michigan  48202
Dana Faber Cancer InstituteBoston, Massachusetts  02115