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

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: August 14, 2007
Last updated: October 10, 2008
Last verified: July 2008
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.

Condition Intervention Phase
Drug: BMS-690514
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of BMS-690514 in Japanese Patients With Solid Tumors

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514 [ Time Frame: administered orally every day 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Safety evaluations and laboratory assessments will be performed [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Preliminary markers of efficacy will also be assessed [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: November 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: BMS-690514
Tablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00516451

Local Institution
Chuo-Ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00516451     History of Changes
Other Study ID Numbers: CA187-006 
Study First Received: August 14, 2007
Last Updated: October 10, 2008
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency processed this record on December 09, 2016