drugset / Trial / NCT00477464
Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-06
- Primary completion
- 2010-12
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 2000 mg/m2 | — |
| Subject | Lapatinib | Small molecule | 1250 mg | — |