A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00351325

Purpose

The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.

Condition	Intervention	Phase
Advanced Solid Malignancies	Drug: BMS-663513	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	A Phase I, Multiple Ascending Dose Study of BMS-663513, an Agonistic Anti-CD137 Monoclonal Antibody, Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To assess the safety and tolerability of multiple ascending doses of BMS-663513 when given in combination with paclitaxel and carboplatin to subjects with advanced malignancies [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Explore PK and PD associations of BMS-663513 and the effect of BMS-663513 on immune system markers. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Describe anti-tumor activity [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Obtain tissue or ascites for exploratory research [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	September 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
dose escalation: Experimental	Drug: BMS-663513 mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Good activity level
Life expectancy of ≥ 6 months
Solid tumor malignancy for which paclitaxel and carboplatin are appropriate

Exclusion Criteria:

Major surgery within 4 weeks
Any concurrent cancer
History of autoimmune diseases
Symptomatic bowel obstruction
Continued use of steroids
Symptomatic brain metastases
Current nerve damage in fingers/toes
Positive for HIV, hepatitis B/C
White blood cells < 3,000
Hemoglobin < 9
Platelets < 100,000
ALT/AST and/or alkaline phosphatase >= 2.5 x ULN
Creatine > 1.5
Prior BMS-663513

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351325

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, Pennsylvania
Magee-Womens Hospital Of Upmc	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Robert Edwards, Site 002 412-641-6253
University Of Pennsylvania Medical Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christina Chu, Site 003
United States, Virginia
University Of Virginia	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Gregory R. Weiss, Site 004
United States, Washington
University Of Washington	Recruiting
Seattle, Washington, United States, 98109
Contact: Ron Swensen, Site 001
Canada, Ontario
Local Institution	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 005

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:	CA186-004
Study First Received:	July 11, 2006
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00351325
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 14, 2009