At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
LDE225 +1 moredrug
Likely dose
LDE225 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Multi-center, Open-label, Single-arm Study of the Efficacy and Safety of Oral LDE225 in Patients With Hh-pathway Activated Relapsed Medulloblastoma
In Brief
A Phase 2 clinical trial evaluating LDE225 and TMZ for Medulloblastoma. Completed, enrolled 22 participants across 41 sites in 13 countries.
Detailed Summary
This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMedulloblastoma
CountriesAustralia, Brazil, Canada, France, Germany, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartMay 2013
Primary CompletionOct 2016
TodayJul 2026
First PostedOct 16, 2012
Enrollment StartMay 6, 2013
Primary CompletionOct 5, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.7 years ago
Interventions
LDE225drug
Sonidegib for oral suspension was supplied in amber glass bottles. Sonidegib oral suspension was combined with the supplied reconstitution vehicle to a final concentration of 50 mg/mL.
TMZdrug
Temozolomide capsules were obtained locally by the Investigator