drugset / Trial / NCT01708174
A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.
Timeline
- Start
- 2013-05-06
- Primary completion
- 2016-10-05
- Completion
- 2016-10-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sonidegib | Small molecule | 500 mg/m2 | Oral |
| Subject | Sonidegib | Small molecule | 600 mg | Oral |
| Comparator | Temozolomide | Small molecule | 150 mg/m2 | — |
| Comparator | Temozolomide | Small molecule | 200 mg/m2 | — |