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Sponsored by: |
Sunesis Pharmaceuticals |
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Information provided by: | Sunesis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00252382 |
The purpose of this study is to evaluate the objective tumor response rate (based on the RECIST criteria) to SNS-595 as a second-line therapy in patients with advanced NSCLC.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung |
Drug: SNS-595 Injection |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Open-Label, Multicenter Clinical Study of the Safety and Efficacy of the Intravenous Administration of SNS-595 as Second-Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 50 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | April 2007 |
Other objectives of this study are to assess the safety, tumor response, time to disease progression, survival rate and to explore several potential biomarkers to see how these levels change after administration of SNS-595.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Premiere Oncology of Arizona | |
Scottsdale, Arizona, United States, 85260 | |
United States, Kentucky | |
Consultants in Blood Disorders and Cancer | |
Louisville, Kentucky, United States, 40207 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center, Duke University | |
Durham, North Carolina, United States, 27705 | |
United States, Tennessee | |
Sarah Cannon Research Institute, LLC | |
Nashville, Tennessee, United States, 37203 |
Study Director: | Glenn Michelson, MD | Sunesis Pharmaceuticals |
Study ID Numbers: | SPO-0005 |
Study First Received: | November 9, 2005 |
Last Updated: | May 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00252382 |
Health Authority: | United States: Food and Drug Administration |
Lung Squamous Cell Large Cell |
Adenocarcinoma Carcinoma Cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |