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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00412880 |
Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Small Cell |
Drug: BI 2536 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Single Group Assignment |
Official Title: | Open Label Phase II Study of BI 2536 BS Monotherapy in Patients With Recurrent Small Cell Lung Cancer |
Enrollment: | 23 |
Study Start Date: | January 2007 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
1216.11.007 Boehringer Ingelheim Investigational Site | |
Fayetteville, Arkansas, United States | |
United States, Illinois | |
1216.11.003 Boehringer Ingelheim Investigational Site | |
Chicago, Illinois, United States | |
1216.11.006 Boehringer Ingelheim Investigational Site | |
Evanston, Illinois, United States | |
United States, Massachusetts | |
1216.11.002 Boehringer Ingelheim Investigational Site | |
Boston, Massachusetts, United States | |
United States, Missouri | |
1216.11.005 Boehringer Ingelheim Investigational Site | |
St. Louis, Missouri, United States | |
United States, North Carolina | |
1216.11.001 Boehringer Ingelheim Investigational Site | |
Chapel Hill, North Carolina, United States | |
United States, South Carolina | |
1216.11.010 Boehringer Ingelheim Investigational Site | |
Greenville, South Carolina, United States | |
1216.11.011 Boehringer Ingelheim Investigational Site | |
Charleston, South Carolina, United States | |
United States, Washington | |
1216.11.012 Boehringer Ingelheim Investigational Site | |
Seattle, Washington, United States | |
Canada, Alberta | |
1216.11.009 Alberta Cancer Board | |
Edmonton, Alberta, Canada |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1216.11 |
Study First Received: | December 18, 2006 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00412880 History of Changes |
Health Authority: | Canada: Health Canada, Therapeutic Products Directorate; United States: Food and Drug Administration |
Thoracic Neoplasms Carcinoma, Neuroendocrine Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Lung Diseases Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Carcinoma, Neuroendocrine Neoplasms, Nerve Tissue Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Glandular and Epithelial |