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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:
ClinicalTrials.gov Identifier:
NCT00351325
First Posted: July 12, 2006
Last Update Posted: September 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: None (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

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 ]

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 ]
  • Describe anti-tumor activity [ Time Frame: throughout the study ]
  • Obtain tissue or ascites for exploratory research [ Time Frame: throughout the study ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00351325     History of Changes
Other Study ID Numbers: CA186-004
First Submitted: July 11, 2006
First Posted: July 12, 2006
Last Update Posted: September 4, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Neoplasms