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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: Paclitaxel; Drug: Brivanib alaninate; Drug: Ixabepilone; Drug: Doxorubicin; Drug: Docetaxel; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798252

CA182-030

2007-005097-31

Details and patient eligibility

About

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

Enrollment: 111 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 5 patient groups

Arm A (Capecitabine + Brivanib alaninate)

Experimental group

Treatment:

Drug: Capecitabine

Drug: Brivanib alaninate

Arm B (Doxorubicin + Brivanib alaninate)

Experimental group

Treatment:

Drug: Doxorubicin

Drug: Brivanib alaninate

Arm C (Ixabepilone + Brivanib alaninate)

Experimental group

Treatment:

Drug: Ixabepilone

Drug: Brivanib alaninate

Arm D (Docetaxel + Brivanib alaninate)

Experimental group

Treatment:

Drug: Docetaxel

Drug: Brivanib alaninate

Arm E (Paclitaxel + Brivanib alaninate)

Experimental group

Treatment:

Drug: Brivanib alaninate

Drug: Paclitaxel