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OpenTrials
Completed

NCT Number: NCT00435669

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

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

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Key information

Conditions

Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brivanib

Drug

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

Other names: BMS-582664

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

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

    Time frame: at last patient last visit

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Mass Balance, Pharmacokinetics and Metabolism of [14C]BMS-582664 Prodrug of BMS-540215, in Subjects With Advanced or Metastatic Solid Tumors

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 15, 2007
Registry last updated
Jan 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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