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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: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| 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 115 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 104864-A/387 |
| Study First Received: | November 18, 2002 |
| Last Updated: | October 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00049998 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Nonsmall Cell Lung cancer advanced Second-line topotecan |
Hycamtin oral docetaxel |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Pharmacologic Actions Carcinoma Docetaxel |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Topotecan Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |