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Completed

NCT Number: NCT00516451

Phase I Study of BMS-690514 in Japanese Patients With Solid Tumors

The purpose of this clinical study is to identify the maximum tolerated dose (MTD) of BMS-690514 once daily orally in Japanese subjects with advanced or metastatic solid tumors.

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Key information

Conditions

Cancer Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Chuo-Ku, Tokyo, 104-0045, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate, with adequate kidney, liver and cardiac function.

Treatment and study plan

BMS-690514

Drug

Tablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more

Primary outcomes

  1. To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514

    Time frame: administered orally every day 28 days

Secondary outcomes

  1. Evaluate safety, exposure levels of BMS-690514 in the body & anticancer activity of BMS-690514 administered orally every day for 28 days.

    Time frame: throughout the study

  2. Safety evaluations and laboratory assessments will be performed

    Time frame: throughout the study

  3. Preliminary markers of efficacy will also be assessed

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 15, 2007
Registry last updated
Oct 13, 2008

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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