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Study of BMS-663513 in Patients With Advanced Cancer

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II, Phase I Treatment Closed 18 and over Pharmaceutical / Industry CA186-001
NCT00309023

Trial Description

Summary

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

Bristol-Myers Squibb

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00309023
Information obtained from ClinicalTrials.gov on May 07, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.