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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00390936
First Posted: October 23, 2006
Last Update Posted: January 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Solid Tumors Drug: Brivanib Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Dose Limiting Toxicity [ Time Frame: at the end of the first cycle of the study ]
  • Maximum Tolerated Dose [ Time Frame: at the end of the first cycle of the study ]

Secondary Outcome Measures:
  • To assess any preliminary evidence of anti-tumor activity observed with BMS-582664 [ Time Frame: at the end of the study ]

Enrollment: 13
Study Start Date: October 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
4 dosages
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390936


Locations
Japan
Local Institution
Sunto-Gun, Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol Myers
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00390936     History of Changes
Other Study ID Numbers: CA182-012
First Submitted: October 20, 2006
First Posted: October 23, 2006
Last Update Posted: January 25, 2011
Last Verified: March 2010