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

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ClinicalTrials.gov Identifier: NCT00461110
Recruitment Status : Terminated
First Posted : April 17, 2007
Last Update Posted : September 4, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: BMS-663513 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2008
Actual Primary Completion Date : April 2009
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers [ Time Frame: end of study ]
  2. Describe anti-tumor activity [ Time Frame: throughout the study ]
  3. Obtain blood and plasma for exploratory research [ Time Frame: several timepoints throughout the study ]
  4. Obtain archival tissue for predictive marker research [ Time Frame: at screening ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00461110     History of Changes
Other Study ID Numbers: CA186-005
First Posted: April 17, 2007    Key Record Dates
Last Update Posted: September 4, 2009
Last Verified: September 2009

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