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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516451
First Posted: August 15, 2007
Last Update Posted: October 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516451


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00516451     History of Changes
Other Study ID Numbers: CA187-006
First Submitted: August 14, 2007
First Posted: August 15, 2007
Last Update Posted: October 13, 2008
Last Verified: July 2008