A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer
Both
Non Small Cell Lung Cancer
Trial Information
A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
throughout the study
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA186-005
NCT ID:
NCT00461110
Start Date:
January 2008
Completion Date:
April 2009
Related Keywords:
- Non Small Cell Lung Cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Texas Southwestern Medical Center | Dallas, Texas |
| The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| NYU Clinical Cancer Center | New York, New York 10016 |
| Thomas Jefferson Univ Hospital | Philadelphia, Pennsylvania 19107 |
