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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00309023 |
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Date of registration:
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29/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of BMS-663513 in Patients With Advanced Cancer
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Scientific title:
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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 |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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103 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00309023 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Canada
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France
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tumors
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Intervention(s)
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Drug: BMS-663513
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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To assess immunogenic potential
[Time Frame: throughout the study]
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To describe efficacy
[Time Frame: throughout the study]
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To assess immune response
[Time Frame: throughout the study]
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To assess the immune response pre and post treatment
[Time Frame: throughout the study]
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Secondary ID(s)
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CA186-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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