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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
Cancer Drug: BMS-690514 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]
  • Safety evaluations and laboratory assessments will be performed [ Time Frame: throughout the study ]
  • Preliminary markers of efficacy will also be assessed [ Time Frame: throughout the study ]

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)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 processed this record on August 17, 2017