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NCT01708174 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB)
A Phase 2 study of Medulloblastoma, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 20
- Study locations
NCT01708174: Completed Phase 2 study of Medulloblastoma, sponsored by Novartis Pharmaceuticals.
NCT01708174 is a Phase 2 study of Medulloblastoma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 22 participants, below the 140-participant average among 29 other Medulloblastoma trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01708174, a Phase 2 study of Medulloblastoma, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.
Primary Outcome
ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) (as per tumor response guidelines and criteria for Medulloblastoma). The IRC evaluated all radiological images and applicable clinical data (i.e., neurological examination, steroid use and cerebrospinal fluid (CSF) results as applicable). Assessments after crossover were not included for TMZ participants.
Conditions Studied
Interventions
- DRUG TMZ
- DRUG LDE225
Study Locations (20)
Other
- Novartis Investigative Site - Angers
- Novartis Investigative Site - Lille
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Toulouse
- Novartis Investigative Site - Vandœuvre-lès-Nancy
- Novartis Investigative Site - Villejuif
Ontario
- Novartis Investigative Site - Toronto
- Novartis Investigative Site - Toronto
Illinois
- Ann & Robert H. Lurie Children Dept of Oncology - Chicago
Maryland
- Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Dept Onc - Baltimore
Massachusetts
- Dana Farber Cancer Institute SC-7 - Boston
New York
- Columbia University Medical Center- New York Presbyterian Dept of Oncology - New York
Ohio
- Cincinnati Children's Hospital Medical Center Division of Hema/Onco. - Cincinnati
Pennsylvania
- Children's Hospital of Pittsburgh Dept of Oncology - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-05-06 |
| Est. Completion | 2016-10-05 |
| Phase | Phase 2 |
What the finished NCT01708174 record still lists
NCT01708174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 140-participant average among 29 other Medulloblastoma trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Medulloblastoma appearing as the primary indexed condition, and to 2 interventions - of which TMZ is the first listed.
NCT01708174 names 20 study sites across 14 states, led by Other, Ontario, Illinois.
Frequently Asked Questions
What is clinical trial NCT01708174 about?
NCT01708174 is a clinical study titled "A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB)". This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.
What is the current status of trial NCT01708174?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2013-05-06. Estimated completion is 2016-10-05.
What conditions does trial NCT01708174 study?
This clinical trial studies the following conditions: Medulloblastoma.
What interventions are being tested in trial NCT01708174?
The interventions under investigation include: TMZ (DRUG), LDE225 (DRUG).
Who is sponsoring clinical trial NCT01708174?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01708174 being conducted?
This trial has 20 study locations across Illinois, Maryland, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Medulloblastoma
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 NCT01708174's enrollment target sits among peer trials
22 23rd of 29 higher than 6 of 29 other Medulloblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Medulloblastoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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