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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00049998 |
Purpose
The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Cancer |
Drug: topotecan |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer |
| Estimated Enrollment: | 760 |
| Study Start Date: | October 2001 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 114 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00049998 History of Changes |
| Other Study ID Numbers: | 104864-A/387 |
| Study First Received: | November 18, 2002 |
| Last Updated: | April 8, 2010 |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Nonsmall Cell Lung cancer advanced Second-line topotecan |
Hycamtin oral docetaxel |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Topotecan Docetaxel Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |