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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: BMS-690514

• Registration Number: NCT00516451
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-14
• Study First Posted: 2007-08-15
• Study Start: 2007-11
• Status Verified: 2008-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Last Update Submitted: 2008-10-10
• Last Update Posted: 2008-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BMS-690514	-

Primary Outcome Measures

Name	Time	Method
To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514	administered orally every day 28 days

Secondary Outcome Measures

Name	Time	Method
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
Safety evaluations and laboratory assessments will be performed	throughout the study
Preliminary markers of efficacy will also be assessed	throughout the study

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Chuo-Ku, Tokyo, Japan