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

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Trial phase: 
Phase I
Recruitment status: 
Active, not recruiting

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.

Background information
Trial ID: 
NCT00390936
Other unique IDs: 
CA182-012
Official title: 

Phase I Multiple Ascending Dose Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Japanese Patients With Advanced or Metastatic Solid Tumors

Detailed description: 

 

Number to be enrolled: 
24 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Both
Eligibility criteria: 

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: 
Treatment
Single Group Assignment
Open Label
Non-Randomized
Uncontrolled
Pharmacokinetics/Dynamics Study
Interventions: 
Brivanib
Conditions treated: 
Solid Tumor
Outcome measurements: 

Dose Limiting Toxicity [ Time Frame: at the end of the first cycle of the study ] [ Designated as safety issue: Yes ]

Maximum Tolerated Dose [ Time Frame: at the end of the first cycle of the study ] [ Designated as safety issue: Yes ]

Funding
Funding types: 
INDUSTRY
Sponsor: 
Bristol-Myers Squibb
Dates
Date the data was first received: 
Fri, 2006-10-20
Trial start date: 
Mon, 2007-10-01
Trial completion date: 
Mon, 2009-06-01
Trial last updated: 
Wed, 2009-05-20