drugset / Trial / NCT00928330
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of trastuzumab.
Timeline
- Start
- 2009-07
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pictilisib | Small molecule | — | Oral |
| Subject | Trastuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Trastuzumab emtansine | Other / unclassified | — | Intravenous |