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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00073008 |
Purpose
This study was designed to evaluate and compare the efficacy of two dose schedules of an oral investigational drug for the treatment of advanced or metastatic non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Cancer |
Drug: GW572016 (lapatinib) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2 Multicenter Trial Comparing Two Schedules of GW572016 as First or Second Line Monotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer With Either Bronchioloalveolar Carcinoma or No Smoking History |
| Enrollment: | 131 |
| Study Start Date: | November 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
lapatinib
Randomized, open-label, parallel group, 2-stage study to evaluate and compare 2 dose schedules (1500 mg QD and 500 mg BID) of oral lapatinib.
|
Drug: GW572016 (lapatinib)
tyrosine kinase inhibitor
|
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 27 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | EGF20014 |
| Study First Received: | November 13, 2003 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00073008 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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GW572016 lapatinib ErbB1 EGFR ErbB2 Her-2/neu |
protein kinase inhibitor NSCLC BAC Advanced metastatic |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Adenocarcinoma, Bronchiolo-Alveolar Enzyme Inhibitors Lapatinib Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |