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Study of BMS-663513 in Patients With Advanced Cancer

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309023
First Posted: March 31, 2006
Last Update Posted: October 12, 2015
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 (Responsible Party):
Bristol-Myers Squibb
  Purpose
This is a Phase I/II, 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, 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 Malignancies

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Assess Safety (Number and distribution and severity adverse events) of subjects [ Time Frame: Active treatment of a minimum of 3 months up until disease progression or toxicity; and long-term follow-up to assess time to progression or death will conclude 2 years after the last treatment with BMS-663513. ]

Secondary Outcome Measures:
  • Efficacy by evaluation of tumor response [ Time Frame: At week 12 and every 6 weeks thereafter. Follow-up up to 2 years after last dose of study drug ]
  • Assess pharmacokinetic parameters deriving from serum concentration versus time data [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1 and 28, Cycle 3 Day 1 and 8, and Day 1 of every cycle the subject is on study from Cycle 4 and greater; and at study discharge. ]
  • Assess pharmacodynamic and immune response analysis [ Time Frame: up to 60 days after last dose of study drug ]

Enrollment: 115
Study Start Date: December 2005
Study Completion Date: September 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, intravenous (IV), 0.3, 1, 3, 6, 10 or 15 mg/kg, once every 3 weeks (q 3 wks), 12 weeks depending on response

  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:

  • Eastern Cooperative Oncology Group (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
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): 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:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00309023     History of Changes
Other Study ID Numbers: CA186-001
First Submitted: March 29, 2006
First Posted: March 31, 2006
Last Update Posted: October 12, 2015
Last Verified: September 2015

Keywords provided by Bristol-Myers Squibb:
Advanced Solid Tumors