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Study 6 of 2651 for search of: | United States, Connecticut |
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Sponsored by: |
OSI Pharmaceuticals |
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Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00373425 |
This is a study to evaluate the effectiveness of Tarceva® (erlotinib) vs. placebo (sugar pill) following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Tarceva Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | RADIANT: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Single-Agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-Small Cell Lung Carcinoma Who Have EGFR-Positive Tumors |
Estimated Enrollment: | 945 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
150 mg Tarceva Daily
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Drug: Tarceva
150 mg
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2: Placebo Comparator
Placebo Tablet Daily
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Drug: Placebo
Placebo Tablet Daily
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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: OSIP Medical Informaiton | 800.572.1932, x7821 | medical-information@osip.com |
Contact: Tarceva Medical Information Direct | 303-546-7821 | medical-information@osip.com |
Responsible Party: | OSI Pharmaceuticals ( Karsten Witt, MD ) |
Study ID Numbers: | OSI-774-302 |
Study First Received: | September 7, 2006 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00373425 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Agency for Health and Food Safety; Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Hungary: National Institute of Pharmacy; Italy: Ethics Committee; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Pharmacological Committee, Ministry of Health; South Korea: Korea Food and Drug Administration (KFDA); Spain: Spanish Agency of Medicines; Taiwan: Department of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
Adjuvant Non-small Cell Lung Cancer Lung Cancer Early-stage Lung Cancer Adjuvant RADIANT NSCLC |
Tarceva EGFR-positive tumor Stage IB Non-small Cell Lung Cancer Stage II Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |