Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib
Part of paid clinical trials in Loma Linda, California.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT00526669
- Phase
- PHASE2
- Status
- Completed
Conditions
- Neoplasms, Gastrointestinal Tract
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lapatinib and Capecitabine — DRUGoral lapatinib (1250mg) administered as a monotherapy run-in followed by its combination with capecitabine
Study Details
The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.
Key Dates
- Start date
- Mar 31, 2008
- Status verified
- Jul 2015
- Primary completion
- Apr 30, 2011
- Completion
- Jan 31, 2015
Study Design
- Enrollment
- 68 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 [ Time Frame: evaluated at baseline and after 7 days of study treatment ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Loma Linda | California | 92354 | - |
| GSK Investigational Site | Los Angeles | California | 90033 | - |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | - |
| GSK Investigational Site | Shreveport | Louisiana | 71103 | - |
| GSK Investigational Site | Ann Arbor | Michigan | 48109 | - |
| GSK Investigational Site | Southgate | Michigan | 48195 | - |
| GSK Investigational Site | Jefferson City | Missouri | 65109 | - |
| GSK Investigational Site | Dallas | Texas | 75137 | - |