A Phase I Study to Determine Absorption, Distribution, Metabolism, and Elimination of a Single Radiolabeled Dose of Brivanib (BMS-582664)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Tumors

Treatments: Drug: Brivanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435669

CA182-008

Details and patient eligibility

About

The purpose of this trial is to determine the mass balance, pharmacokinetics, metabolism, and routes and extent of elimination of BMS-582664

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic/cytologic diagnosis of advanced or metastatic solid tumors
• ECOG 0-2
• 4/6 weeks since prior therapy

Exclusion criteria

• Brain metastases
• Secondary primary malignancy
• Thromboembolic disease requiring full anticoagulation within 6 months
• Inability to swallow or absorb oral therapy
• Uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)