A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
- Registration Number
- NCT00461110
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- NSCLC who are eligible to receive a 6 week course of RT
- Part 1 - not candidates for definitive RT
- Part 2 - candidates for definitive RT
Exclusion Criteria
- Severe COPD, pulmonary infection or interstitial pneumonitis
- Recent cellulitis
- Autoimmune disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 BMS-663513 Active 2 BMS-663513 Active
- Primary Outcome Measures
Name Time Method To determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma throughout the study
- Secondary Outcome Measures
Name Time Method Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers end of study Describe anti-tumor activity throughout the study Obtain archival tissue for predictive marker research at screening Obtain blood and plasma for exploratory research several timepoints throughout the study
Trial Locations
- Locations (4)
The Cancer Institute Of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Nyu Clinical Cancer Center
🇺🇸New York, New York, United States
Thomas Jefferson Univ Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University Of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
The Cancer Institute Of New Jersey🇺🇸New Brunswick, New Jersey, United States