drugset / Trial / NCT00930475
Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Phase 1/2
Unknown
54 enrolled
Charite University, Berlin, Germany
KKS Netzwerk · collabNovartis Pharmaceuticals · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label, mono-center phase I/II study designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of RAD001 in combination with carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer. Additionally, the study is designed to characterize the safety, the tolerability and efficacy of this study.
Timeline
- Start
- 2009-02
- Primary completion
- 2010-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 2.5 mg | — |
| Subject | Everolimus | Small molecule | 5 mg | — |
| Subject | Everolimus | Small molecule | 7.5 mg | — |
| Subject | Everolimus | Small molecule | 10 mg | — |
| Background | Carboplatin | Small molecule | — | Intravenous |