CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
LDE225drug
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.

Search/NCT01125800
NCT01125800Phase 2Completed
CompareCT.gov

A Phase I/II Study of LDE225 in Pediatric Patients With Recurrent or Refractory Medulloblastoma or Other Tumors Potentially Dependent on the Hedgehog-signaling Pathway and Adult Patients With Recurrent or Refractory Medulloblastoma

Novartis Pharmaceuticals·interventional·Posted May 18, 2010·Updated Mar 20, 2017

In Brief

A Phase 2 clinical trial evaluating LDE225 for Medulloblastoma and 5 related conditions. Completed, enrolled 76 participants across 14 sites in 6 countries.

Detailed Summary

Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent or refractory medulloblastoma, or other tumors potentially dependent on Hedgehog signaling pathway. Phase II study is to assess preliminary efficacy in both adult and pediatric patients with recurrent or refractory MB.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMedulloblastoma, Rhabdomyosarcoma, Neuroblastoma, Hepatoblastoma, Glioma, Astrocytoma
CountriesAustralia, Canada, France, Italy, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2010
Enrollment StartFeb 1, 2011
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 16.1 years ago

Interventions

LDE225drug

LDE225/sonidegib capsules were supplied to the Investigators at dose strengths of 50 mg, 100 mg, 200 mg, and 250 mg.