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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
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00390936     History of Changes
Other Study ID Numbers: CA182-012
Study First Received: October 20, 2006
Last Updated: January 24, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013