drugset / Trial / NCT01044485
Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
Phase 1/2
Completed
17 enrolled
Centre Georges Francois Leclerc
GlaxoSmithKline · collabSanofi · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The objective of this phase I/ II study is therefore to assess the safety and efficacy of lapatinib in combination with docetaxel in patients with advanced cancer. Only patients in first line treatment for metastatic disease should be included in the present study. It is proposed to start with a phase I part evaluating the safety of lapatinib 1250 mg with docetaxel 75 mg/m² without systematic support of growth factors, starting after the completion and data from the 1000 mg lapatinib +75 mg/m² docetaxel dose level in the EORTC (Bonnefoi) study.The objective of the phase II part will confirm the safety and evaluate efficacy of lapatinib in combination with docetaxel.
Timeline
- Start
- 2008-11
- Primary completion
- 2011-11
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 100 mg/m2 | — |
| Subject | Lapatinib | Small molecule | 1250 mg | Oral |
| Subject | Lapatinib | Small molecule | 1500 mg | Oral |