drugset / Trial / NCT01954355
LDE225 and Paclitaxel in Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
The primary aim of this trial is to establish the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of LDE225 given in combination with standard doses of paclitaxel in patients with advanced solid tumors. In addition, the preliminary anti-tumor activity of this combination will be assessed, in particular in ovarian cancer.
Timeline
- Start
- 2013-09
- Primary completion
- 2015-10
- Completion
- 2016-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sonidegib | Small molecule | 400 mg | — |
| Subject | Sonidegib | Small molecule | 600 mg | — |
| Subject | Sonidegib | Small molecule | 800 mg | — |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | — |