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

September 3, 2009 updated by: Bristol-Myers Squibb

A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • The Cancer Institute of New Jersey
    • New York
      • New York, New York, United States, 10016
        • Nyu Clinical Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Univ Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Anti-CD137

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Describe anti-tumor activity
Time Frame: throughout the study
throughout the study
Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers
Time Frame: end of study
end of study
Obtain blood and plasma for exploratory research
Time Frame: several timepoints throughout the study
several timepoints throughout the study
Obtain archival tissue for predictive marker research
Time Frame: at screening
at screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

April 13, 2007

First Submitted That Met QC Criteria

April 13, 2007

First Posted (Estimate)

April 17, 2007

Study Record Updates

Last Update Posted (Estimate)

September 4, 2009

Last Update Submitted That Met QC Criteria

September 3, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA186-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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