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A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB)
NCT01708174 · View on ClinicalTrials.gov ↗
Study Summary
This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01708174
The ClinicalTrials.gov registry entry for NCT01708174 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01708174 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Ontario, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01708174?
The interventions under investigation include: TMZ (DRUG), LDE225 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01708174?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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