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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 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.

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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.

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

FieldValue
Enrollment Target 22 participants
Start Date 2013-05-06
Est. Completion 2016-10-05
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01708174

The ClinicalTrials.gov registry entry for NCT01708174 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 29 other Medulloblastoma trials with a reported enrollment target (84% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.