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

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00351325
First received: July 11, 2006
Last updated: September 3, 2009
Last verified: September 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Bristol-Myers Squibb
  More Information

Additional Information:
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 November 25, 2014