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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00130728 |
This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Cancer |
Drug: bevacizumab Drug: erlotinib HCl Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy |
Estimated Enrollment: | 650 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | October 2009 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: bevacizumab
Intravenous repeating dose
Drug: erlotinib HCl
oral repeating dose
|
2: Placebo Comparator |
Drug: erlotinib HCl
oral repeating dose
Drug: placebo
Intravenous repeating dose
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Paula O'Connor, M.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Paula O'Connor, M.D., Study Director ) |
Study ID Numbers: | OSI3364g |
Study First Received: | August 12, 2005 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00130728 |
Health Authority: | United States: Food and Drug Administration |
NSCLC Avastin Tarceva Lung Cancer |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Bevacizumab Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |