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Study 17 of 5951 for search of: | United States, North Carolina |
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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00403403 |
This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage SCLC.
Condition | Intervention | Phase |
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Small Cell Lung Cancer |
Drug: bevacizumab Drug: chemotherapy Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: bevacizumab
Intravenous repeating dose
Drug: chemotherapy
Repeating dose
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2: Placebo Comparator |
Drug: chemotherapy
Repeating dose
Drug: placebo
Intravenous repeating dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Genentech Trial Information Support Line | 888-662-6728 |
Study Director: | Jane Huang, M.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Jane Huang, M.D., Study Director ) |
Study ID Numbers: | AVF3995g |
Study First Received: | November 21, 2006 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00403403 |
Health Authority: | United States: Food and Drug Administration |
SCLC SALUTE Lung Cancer Avastin |
Thoracic Neoplasms Carcinoma, Neuroendocrine Bevacizumab Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |