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Activation of the Sonic Hedgehog (SHH) Pathway clinical trials

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NCT ID: NCT01601184 Terminated - Clinical trials for Histologically Confirmed Medulloblastoma

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

Start date: June 2012
Phase: Phase 1/Phase 2
Study type: Interventional

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.