Status:
TERMINATED
Study of BMS-663513 in Patients With Advanced Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 tumor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00309023
Start Date
December 1 2005
End Date
September 1 2009
Last Update
October 12 2015
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
City Of Hope National Medical Center
Duarte, California, United States, 91010
2
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
3
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215