A Study of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: Brivanib

• Registration Number: NCT00390936
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-20
• Study First Submitted QC: 2006-10-20
• Study First Posted: 2006-10-23
• Study Start: 2007-10
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Patients must have measurable disease
• Documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator
• ECOG PS: 0-1

Exclusion Criteria

• Subjects with centrally located squamous cell carcinoma of the lung

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Brivanib	4 dosages

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	at the end of the first cycle of the study
Maximum Tolerated Dose	at the end of the first cycle of the study

Secondary Outcome Measures

Name	Time	Method
To assess any preliminary evidence of anti-tumor activity observed with BMS-582664	at the end of the study

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Sunto-Gun, Shizuoka, Japan