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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00516451

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 I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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
1: Experimental	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, Tokyo
Local Institution
Chuo-Ku, Tokyo, Japan, 104-0045

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA187-006
Study First Received:	August 14, 2007
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00516451
Health Authority:	United States: Food and Drug Administration; Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on January 16, 2009