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

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 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

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:

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
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: dose escalation	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

Locations

United States, Pennsylvania
University Of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Magee-Womens Hospital Of Upmc
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
University Of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
University Of Washington
Seattle, Washington, United States, 98109
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

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:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00351325 History of Changes
Other Study ID Numbers:	CA186-004
Study First Received:	July 11, 2006
Last Updated:	September 3, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013