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NCT02111187 · ClinicalTrials.gov registry record · Phase 1
A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02111187: Completed Phase 1 study of Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT02111187 is a Phase 1 study of Prostate Cancer that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 14 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02111187, a Phase 1 study of Prostate Cancer, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This was defined as the number of patients who achieved at least a two-fold reduction in GLI1 expression in post-treatment vs. pre-treatment tumor tissues.
Conditions Studied
Interventions
- DRUG LDE225
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-04 |
| Est. Completion | 2017-01-18 |
| Phase | Phase 1 |
What the finished NCT02111187 record still lists
NCT02111187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which LDE225 is the first listed.
NCT02111187 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02111187 about?
NCT02111187 is a clinical study titled "A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer". 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 ...
What is the current status of trial NCT02111187?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2014-04. Estimated completion is 2017-01-18.
What conditions does trial NCT02111187 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT02111187?
The interventions under investigation include: LDE225 (DRUG).
Who is sponsoring clinical trial NCT02111187?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02111187 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02111187's enrollment target sits among peer trials
14 693rd of 735 higher than 39 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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