A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies
- Registration Number
- NCT00351325
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- Good activity level
- Life expectancy of ≥ 6 months
- Solid tumor malignancy for which paclitaxel and carboplatin are appropriate
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dose escalation BMS-663513 -
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of multiple ascending doses of BMS-663513 when given in combination with paclitaxel and carboplatin to subjects with advanced malignancies throughout the study
- Secondary Outcome Measures
Name Time Method Explore PK and PD associations of BMS-663513 and the effect of BMS-663513 on immune system markers. throughout the study Describe anti-tumor activity throughout the study Obtain tissue or ascites for exploratory research throughout the study
Trial Locations
- Locations (5)
University Of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Magee-Womens Hospital Of Upmc
🇺🇸Pittsburgh, Pennsylvania, United States
University Of Virginia
🇺🇸Charlottesville, Virginia, United States
University Of Washington
🇺🇸Seattle, Washington, United States
Local Institution
🇨🇦Toronto, Ontario, Canada
University Of Pennsylvania Medical Center🇺🇸Philadelphia, Pennsylvania, United States