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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
Not Enrolling
Both
Non Small Cell Lung Cancer

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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