|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00065182 |
Purpose
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 |
|---|---|---|
|
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 |
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 81 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 104864/615 |
| Study First Received: | July 17, 2003 |
| Last Updated: | May 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00065182 History of Changes |
| 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 |
|
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 |