Back to resultsA Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
Primary Purpose
Non Small Cell Lung Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-663513
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility 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
Sites / Locations
- The Cancer Institute Of New Jersey
- Nyu Clinical Cancer Center
- Thomas Jefferson Univ Hospital
- University Of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Active
Active
Outcomes
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
Secondary Outcome Measures
Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers
Describe anti-tumor activity
Obtain blood and plasma for exploratory research
Obtain archival tissue for predictive marker research
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00461110
Brief Title
A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
Official Title
A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Active
Arm Title
2
Arm Type
Experimental
Arm Description
Active
Intervention Type
Drug
Intervention Name(s)
BMS-663513
Other Intervention Name(s)
Anti-CD137
Intervention Description
mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers
Time Frame
end of study
Title
Describe anti-tumor activity
Time Frame
throughout the study
Title
Obtain blood and plasma for exploratory research
Time Frame
several timepoints throughout the study
Title
Obtain archival tissue for predictive marker research
Time Frame
at screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
The Cancer Institute Of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Nyu Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Thomas Jefferson Univ Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University Of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
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