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

Bristol-Myers Squibb4 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tumors

Interventions

BrivanibDRUG

Oral Solution, Oral, 800 mg, X1 on Day 1, 10 D for ADME

BrivanibDRUG

Tablet, Oral, Brivanib 800 mg, QD, until progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Absorption

Time frame: Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10

Distribution

Time frame: Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10

Metabolism

Time frame: Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10

Elimination of BMS-582664

Time frame: Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10

Secondary Outcomes

To assess safety and tolerability of BMS-582664 800 mg administered daily in Part B

Time frame: at last patient last visit

Data from ClinicalTrials.gov

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