A Study Of Oral GW572016 In Advanced Or Metastatic Non-Small Cell Lung Cancer
Part of paid clinical trials in Jasper, Alabama.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT00073008
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Lung Cancer, Non-Small Cell
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- GW572016 (lapatinib) — DRUGtyrosine kinase inhibitor
Study Details
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.
Key Dates
- Start date
- Nov 30, 2003
- Status verified
- Jan 2017
- Primary completion
- Jul 31, 2008
- Completion
- Jul 31, 2008
Study Design
- Enrollment
- 131 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: lapatinibRandomized, open-label, parallel group, 2-stage study to evaluate and compare 2 dose schedules (1500 mg once daily and 500 mg twice daily) of oral lapatinib.
Primary Outcome Measure
Tumor Response in the Targeted Population Through the End of Treatment [ Time Frame: Baseline and then every 8 weeks through end of treatment ]
Locations (23)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Jasper | Alabama | 35501 | - |
| GSK Investigational Site | Greenbrae | California | 94904-2007 | - |
| GSK Investigational Site | La Jolla | California | 92037 | - |
| GSK Investigational Site | Long Beach | California | 90813 | - |
| GSK Investigational Site | Poway | California | 92064 | - |
| GSK Investigational Site | Rancho Mirage | California | 92270 | - |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | - |
| GSK Investigational Site | Gainsville | Florida | 32610 | - |
| GSK Investigational Site | Elk Grove Village | Illinois | 60007 | - |
| GSK Investigational Site | Houma | Louisiana | 70360 | - |
| GSK Investigational Site | Metairie | Louisiana | 70006 | - |
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | - |
| GSK Investigational Site | New Brunswick | New Jersey | 08901 | - |
| GSK Investigational Site | Santa Fe | New Mexico | 87505 | - |
| GSK Investigational Site | Nyack | New York | 10960 | - |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599-7600 | - |
| GSK Investigational Site | Durham | North Carolina | 27707 | - |
| GSK Investigational Site | Cleveland | Ohio | 44106 | - |
| GSK Investigational Site | Portland | Oregon | 97213 | - |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | - |
| GSK Investigational Site | Nashville | Tennessee | 37203 | - |
| GSK Investigational Site | Corpus Christi | Texas | 78412 | - |
| GSK Investigational Site | Houston | Texas | 77030 | - |
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