Status:
TERMINATED
A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Solid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.
Eligibility Criteria
Inclusion
- Good activity level
- Life expectancy of ≥ 6 months
- Solid tumor malignancy for which paclitaxel and carboplatin are appropriate
Exclusion
- Major surgery within 4 weeks
- Any concurrent cancer
- History of autoimmune diseases
- Symptomatic bowel obstruction
- Continued use of steroids
- Symptomatic brain metastases
- Current nerve damage in fingers/toes
- Positive for HIV, hepatitis B/C
- White blood cells \< 3,000
- Hemoglobin \< 9
- Platelets \< 100,000
- ALT/AST and/or alkaline phosphatase \>= 2.5 x ULN
- Creatine \> 1.5
- Prior BMS-663513
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00351325
Start Date
September 1 2007
End Date
March 1 2009
Last Update
September 4 2009
Active Locations (5)
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1
University Of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
2
Magee-Womens Hospital Of Upmc
Pittsburgh, Pennsylvania, United States, 15213
3
University Of Virginia
Charlottesville, Virginia, United States, 22908
4
University Of Washington
Seattle, Washington, United States, 98109