A Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2 Positive Breast Cancer
Part of paid clinical trials in Greenville, South Carolina.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT00849329
- Phase
- PHASE1
- Status
- Completed
Conditions
- Neoplasms, Breast
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- lapatinib — DRUG1250mg lapatinib
- lapatinib plus esomeprazole — DRUG1250mg lapatinib plus esomeprazole 40mg
Study Details
This study will characterize the effect of elevated gastric pH mediated by the proton-pump inhibitor, esomeprazole, on the relative bioavailability of lapatinib in subjects with metastatic ErbB2 positive breast cancer.
Key Dates
- Start date
- Mar 10, 2009
- Status verified
- Nov 2017
- Primary completion
- Nov 24, 2009
- Completion
- Nov 24, 2009
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Period 11250mg lapatinib once daily in the morning
- Experimental: Period 21250mg lapatinib once daily in the morning in combination with esomeprazole 40mg once daily at bedtime.
Primary Outcome Measure
The area under the concentration versus time curve, minimum observed concentration, maximum observed concentration, time at which it occurs, and lag time in the appearance of measurable plasma concentrations of lapatinb [ Time Frame: Continue until disease progression or withdrawal consent ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Greenville | South Carolina | 29605 | - |
Find similar trials in Greenville, SC
By research site