Trials / Completed
CompletedNCT00371488
GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer
Phase I Study of Lapatinib in Combination With Trastuzumab
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 20 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GW572016 oral tablets | Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets. |
Timeline
- Start date
- 2006-04-06
- Primary completion
- 2007-12-10
- Completion
- 2007-12-10
- First posted
- 2006-09-04
- Last updated
- 2018-08-31
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00371488. Inclusion in this directory is not an endorsement.