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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00516451
First received: August 14, 2007
Last updated: October 10, 2008
Last verified: July 2008
  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
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

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Bristol-Myers Squibb

Additional 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
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

ClinicalTrials.gov processed this record on April 22, 2014