MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00207103

Purpose

This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.

Condition	Intervention	Phase
Tumors Neoplasm Metastasis	Drug: Brivanib Drug: Brivanab	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, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Safety assessment [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
dose-limiting toxicity (DLT) [ Time Frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified ] [ Designated as safety issue: Yes ]
determination of maximum tolerated dose (MTD) [ Time Frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy based on duration of response and time to progression based on assessment [ Time Frame: measured every 8 weeks throughout the study ] [ Designated as safety issue: No ]

Enrollment:	68
Study Start Date:	September 2004
Study Completion Date:	September 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Brivanib Tablets, Oral, 180 mg, once daily, until disease progression
2: Experimental	Drug: Brivanib Tablets, Oral, 320 mg, once daily, until disease progression
3: Experimental	Drug: Brivanib Tablets, Oral, 600 mg, once daily, until disease progression
4: Experimental	Drug: Brivanib Tablets, Oral, 800 mg, once daily, until disease progression
5: Experimental	Drug: Brivanib Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
6: Experimental	Drug: Brivanab Tablets, Oral, 1000 mg, once daily, until disease progression

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
No tumor spread to the brain
Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
Available tumor tissue sample from prior surgery
4-6 weeks since prior therapy and recovered from prior therapy
Men and women, ages 18 and above
Women must not be pregnant or breastfeeding
Diagnosis of advanced or metastatic (tumor that has spread) colorectal, hepatocellular (liver) or renal (kidney) cancer
Measurable disease on scans (at least one)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207103

Locations

United States, California
Premiere Oncology
Santa Monica, California, United States, 90404
United States, Indiana
Indiana University Med Center
Indianapolis, Indiana, United States, 46202
United States, Wisconsin
University Of Wisconsin Comprehensive Center
Madison, Wisconsin, United States, 53792
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 1C4
Italy
Local Institution
Milano, Italy, 20141
United Kingdom, Greater London
Local Institution
Middlesex, Greater London, United Kingdom, HA6 2RN
United Kingdom, Greater Manchester
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA182-002
Study First Received:	September 12, 2005
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00207103
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Advanced metastatic or solid tumors

Study placed in the following topic categories:

Neoplasm Metastasis

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009