drugset / Trial / NCT01482156
Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
Study has two parts: 1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors. 2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer
Timeline
- Start
- 2012-01
- Primary completion
- 2015-02
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dactolisib | Small molecule | 50 mg | Oral |
| Subject | Dactolisib | Small molecule | 100 mg | Oral |
| Subject | Dactolisib | Small molecule | 200 mg | Oral |
| Subject | Dactolisib | Small molecule | 300 mg | Oral |
| Subject | Dactolisib | Small molecule | 400 mg | Oral |
| Subject | Everolimus | Small molecule | 2.5 mg | Oral |
| Subject | Everolimus | Small molecule | 5 mg | Oral |
| Subject | Everolimus | Small molecule | 10 mg | Oral |