Non Small Cell Lung Cancer Clinical Trial
Official title:
A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
Verified date | September 2009 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 35 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University Of Texas Southwestern Medical Center | Dallas | Texas |
United States | The Cancer Institute Of New Jersey | New Brunswick | New Jersey |
United States | Nyu Clinical Cancer Center | New York | New York |
United States | Thomas Jefferson Univ Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | throughout the study | Yes | |
Secondary | Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers | end of study | No | |
Secondary | Describe anti-tumor activity | throughout the study | No | |
Secondary | Obtain blood and plasma for exploratory research | several timepoints throughout the study | No | |
Secondary | Obtain archival tissue for predictive marker research | at screening | No |
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