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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00390936
First received: October 20, 2006
Last updated: January 24, 2011
Last verified: March 2010

October 20, 2006
January 24, 2011
October 2007
March 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Dose Limiting Toxicity
  • Maximum Tolerated Dose
Complete list of historical versions of study NCT00390936 on ClinicalTrials.gov Archive Site
To assess any preliminary evidence of anti-tumor activity observed with BMS-582664 [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
To assess any preliminary evidence of anti-tumor activity observed with BMS-582664
Not Provided
Not Provided
 
A Study of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
Drug: Brivanib
Tablet, Oral, Brivanib 300 mg, 600 mg, 800 mg, 1000 mg, once daily (cycle 1: Day 1, Day 8 - 35), more than 5 weeks depending on response/toxicity
Other Name: BMS-582664
No Intervention: 1
4 dosages
Intervention: Drug: Brivanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00390936
CA182-012
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol Myers
Bristol-Myers Squibb
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP