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Trial record 5 of 7 for:    BMS-663513
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Study of BMS-663513 in Patients With Advanced Cancer

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00309023
First received: March 29, 2006
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  Purpose

This is a Phase I, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137 monoclonal antibody, administered every three weeks to patients with metastatic or locally advanced solid tumors.


Condition Intervention Phase
Tumors
 Drug: BMS-663513
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Ascending Multi-Dose Study of BMS-663513, An Agonistic Anti-CD137 Monoclonal Antibody, Administered Every Three Weeks to Patients With Metastatic or Locally Advanced Solid Tumors

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 BMS-663513 in the range of 0.3 mg/kg to 15 mg/kg administered once every 3 weeks [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the immune response pre and post treatment [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To describe efficacy [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To assess immunogenic potential [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To assess immune response [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 103
Study Start Date: December 2005
Estimated Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dose escalation Drug: BMS-663513
mg/kg, IV, 0.3, 1, 3, 6, 10 or 15 mg/kg, q 3 wks, 12 weeks depending on response

  Eligibility

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

Inclusion Criteria:

  • ECOG score of 0-1.
  • Measurable disease.
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm3
  • Platelet count >= 100K cells/mm3
  • Hemoglobin >= 9.0 g/dL
  • Total bilirubin <= 1.5 x IULN
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase <= 2.5 x institutional upper limit of normal (IULN)
  • Patients with advanced solid malignancies must have melanoma, renal or ovarian carcinoma

Exclusion Criteria:

  • History of autoimmune diseases.
  • Condition requiring the continued use of systemic or topical steroids or the use of immunosuppressive agents.
  • Active/symptomatic brain metastasis.
  • History of hepatitis B or C.
  • Concurrent malignancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309023

Locations
United States, California
City Of Hope National Medical Center
Duarte, California, United States, 91010
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2M9
France
Local Institution
Bordeaux, France, 33076
Local Institution
Paris, France, 75004
Local Institution
Paris, France, 75908
Local Institution
Saint Herblain, France, 44805
Local Institution
Villejuif Cedex, France, 94800
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb 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: NCT00309023     History of Changes
Other Study ID Numbers: CA186-001
Study First Received: March 29, 2006
Last Updated: September 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Advanced Solid Tumors

ClinicalTrials.gov processed this record on May 19, 2013