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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516451
• Other study ID #: CA187-006
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2007
• Last updated: October 10, 2008
• Start date: November 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• BMS-690514
Tablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more

Locations

Country	Name	City	State
Japan	Local Institution	Chuo-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514		administered orally every day 28 days	Yes
Secondary	Evaluate safety, exposure levels of BMS-690514 in the body & anticancer activity of BMS-690514 administered orally every day for 28 days.		throughout the study	Yes
Secondary	Safety evaluations and laboratory assessments will be performed		throughout the study	Yes
Secondary	Preliminary markers of efficacy will also be assessed		throughout the study	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm