Trials / Completed
CompletedNCT00477464
Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
Clinical Evaluation of Lapatinib Administered With Capecitabine in Japanese Patients With ErbB2 Overexpressing Advanced or Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the safety and efficacy of lapatinib taken together with capecitabine in Japanese patients. The study will proceed in two phases; the first phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters. If there are no major safety concerns in Part 1, the study will move into the second phase (Part 2) to further evaluate the safety and clinical activity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lapatinib | 1250mg once daily |
| DRUG | capecitabine | 2000mg/m\^2 twice daily (14 days out of 21 days) |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2007-05-23
- Last updated
- 2018-09-17
- Results posted
- 2011-09-05
Locations
15 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00477464. Inclusion in this directory is not an endorsement.