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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00065182 |
The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.
Condition | Intervention | Phase |
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Non-Small-Cell Lung Cancer |
Drug: Topotecan/Docetaxel combination Drug: Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Multicenter, Randomized, Phase III Study Comparing Combination IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Advanced (IIIB/IV) Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 408 |
Study Start Date: | August 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104864/615 |
Study First Received: | July 17, 2003 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00065182 |
Health Authority: | United States: Food and Drug Administration; Canada: Canadian Institutes of Health Research; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
HYCAMTIN topotecan docetaxel TAXOTERE |
non-small cell lung cancer NSCLC Advanced Stage IIIB/IV |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Topotecan 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 |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |