At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 70 enrolled
Drug / intervention
LDE225drug
Likely dose
LDE225 200 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, Randomized Study to Assess Safety and Efficacy of Two Different Schedules of Oral LDE225 in Adult Patients With Relapsed/Refractory or Untreated Elderly Patients With Acute Leukemia
In Brief
A Phase 2 clinical trial evaluating LDE225 for Acute Leukemias. Completed, enrolled 70 participants across 23 sites in 11 countries.
Detailed Summary
The study will evaluate the efficacy, safety and tolerability of two dosing schedules of LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated acute leukemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Leukemias
CountriesAustralia, Austria, Belgium, Canada, Germany, Hungary, Netherlands, Norway, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 2013
Enrollment StartMay 2013
Primary CompletionMay 2015
TodayJul 2026
First PostedApr 8, 2013
Enrollment StartMay 1, 2013
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 13.2 years ago
Interventions
LDE225drug
LDE225 will be supplied as 200 mg capsules by Novartis. Patients will receive study treatment on an outpatient basis. LDE225 will be dispensed every two weeks for the first four weeks and at the start of every four weeks thereafter, as needed.