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

This study is ongoing, but not recruiting participants.

First Received: October 20, 2006 Last Updated: May 6, 2009 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00390936

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 Tumor	Drug: Brivanib	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Brivanib alaninate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
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 ] [ 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 ]

Estimated Enrollment:	24
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention 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

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, Shizuoka
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

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:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA182-012
Study First Received:	October 20, 2006
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00390936 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on May 07, 2009