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A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00461110
First received: April 13, 2007
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
 Drug: BMS-663513
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Describe anti-tumor activity [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Obtain blood and plasma for exploratory research [ Time Frame: several timepoints throughout the study ] [ Designated as safety issue: No ]
  • Obtain archival tissue for predictive marker research [ Time Frame: at screening ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: January 2008
Estimated Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active
 Drug: BMS-663513
mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks
Other Name: Anti-CD137
Experimental: 2
Active
 Drug: BMS-663513
mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks
Other Name: Anti-CD137

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461110

Locations
United States, New Jersey
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Nyu Clinical Cancer Center
New York, New York, United States, 10016
United States, Pennsylvania
Thomas Jefferson Univ Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
University Of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00461110     History of Changes
Other Study ID Numbers: CA186-005
Study First Received: April 13, 2007
Last Updated: September 3, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013