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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00449033 |
Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)
Condition | Intervention | Phase |
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NSCLC Carcinoma, Non-Small-Cell Lung |
Drug: Nexavar (Sorafenib, BAY43-9006) plus gemcitabine and cisplatin Drug: placebo plus gemcitabine and cisplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized, Double-Blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 350 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Nexavar (Sorafenib, BAY43-9006) plus gemcitabine and cisplatin
Multikinase inhibitor plus chemotherapy: Gemcitabine 1250 mg/m² IV, Cisplatin 75 mg/m² IV , Sorafenib 400 mg po bid
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Arm 2: Placebo Comparator |
Drug: placebo plus gemcitabine and cisplatin
Chemotherapy: Gemcitabine 1250 mg/m² IV, Cisplatin 75 mg/m² IV, Placebo 2 tablets po bid
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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: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
Study ID Numbers: | 12006, EudraCT 2006-002688-26 |
Study First Received: | March 16, 2007 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00449033 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Non-Small Cell Lung Cancer (NSCLC) Cancer |
Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Gemcitabine Sorafenib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Anti-Infective Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |