Overview

Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway

Status:
Terminated

Trial end date:
2017-10-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the safety of vismodegib in combination with temozolomide (primary objective - phase I) and to estimate the efficacy of vismodegib in combination with temozolomide in adult patients with recurrent, progressive, or refractory medulloblastomas to standard therapy measured by the 6-month progression-free rate (phase II). This study is an open-label Phase I/II, international, randomized. 38 patients will be included in the study.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Centre Leon Berard

Collaborator:

Ministry of Health, France

Treatments:

Dacarbazine
Temozolomide