At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
LDE225drug
Likely dose
LDE225 800mgfrom 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 Pharmacodynamic Pre-surgical Study of Hedgehog Pathway Inhibition With LDE225 in Men With High-risk Localized Prostate Cancer.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Apr 11, 2014·Updated Mar 7, 2019
In Brief
A Phase 1 clinical trial evaluating LDE225 for Prostate Cancer. Completed, enrolled 14 participants across 1 site.
Detailed Summary
This trial is designed as a randomized two-arm (LDE225 vs. observation groups) open-label prospective clinical trial in men with localized high-risk prostate cancer undergoing radical prostatectomy. The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue from men at high risk of systemic disease progression, by comparing pre-surgical core-biopsy specimens to tumor tissue harvested at the time of prostatectomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionJan 2017
TodayJul 2026
First PostedApr 11, 2014
Enrollment StartApr 1, 2014
Primary CompletionJan 18, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.2 years ago
Interventions
LDE225drug
Sonidegib was given as an oral drug at 800mg daily for 28 days prior to prostetoctomy