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Completed

NCT Number: NCT00390936

A Study of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.

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Key information

Conditions

Solid Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Sunto-Gun, Shizuoka, 411-8777, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have measurable disease
  • Documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator
  • ECOG PS: 0-1

Exclusion criteria

  • Subjects with centrally located squamous cell carcinoma of the lung

Treatment and study plan

Brivanib

Drug

Tablet, Oral, Brivanib 300 mg, 600 mg, 800 mg, 1000 mg, once daily (cycle 1: Day 1, Day 8 - 35), more than 5 weeks depending on response/toxicity

Other names: BMS-582664

Primary outcomes

  1. Dose Limiting Toxicity

    Time frame: at the end of the first cycle of the study

  2. Maximum Tolerated Dose

    Time frame: at the end of the first cycle of the study

Secondary outcomes

  1. To assess any preliminary evidence of anti-tumor activity observed with BMS-582664

    Time frame: at the end of the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Phase I Multiple Ascending Dose Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Japanese Patients With Advanced or Metastatic Solid Tumors

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 23, 2006
Registry last updated
Jan 25, 2011

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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