NCT01708174 - A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 6, 2013

Primary Completion Date

October 5, 2016

Study Completion Date

October 5, 2016

Conditions

Medulloblastoma

Interventions

DRUG

LDE225

Sonidegib for oral suspension was supplied in amber glass bottles. Sonidegib oral suspension was combined with the supplied reconstitution vehicle to a final concentration of 50 mg/mL.

DRUG

TMZ

Temozolomide capsules were obtained locally by the Investigator

Trial Locations (41)

4029

Novartis Investigative Site, Herston

6840

Novartis Investigative Site, Perth

8032

Novartis Investigative Site, Zurich

10032

Columbia University Medical Center- New York Presbyterian Dept of Oncology, New York

10126

Novartis Investigative Site, Torino

20133

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

21231

Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Dept Onc, Baltimore

28009

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

31059

Novartis Investigative Site, Toulouse

33076

Novartis Investigative Site, Bordeaux

40139

Novartis Investigative Site, Bologna

41013

Novartis Investigative Site, Seville

45147

Novartis Investigative Site, Essen

46026

Novartis Investigative Site, Valencia

49033

Novartis Investigative Site, Angers

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

59020

Novartis Investigative Site, Lille

60611

Ann & Robert H. Lurie Children Dept of Oncology, Chicago

75231

Novartis Investigative Site, Paris

86156

Novartis Investigative Site, Augsburg

94805

Novartis Investigative Site, Villejuif

98105

Seattle Cancer Care Alliance Dept Oncology, Seattle

101126

Novartis Investigative Site, Torino

117198

Novartis Investigative Site, Moscow

02215

Dana Farber Cancer Institute SC-7, Boston

45229-3039

Cincinnati Children's Hospital Medical Center Division of Hema/Onco., Cincinnati

15213-2583

Children's Hospital of Pittsburgh Dept of Oncology, Pittsburgh

77030-4009

University of Texas/MD Anderson Cancer Center SC-3, Houston

Unknown

Novartis Investigative Site, São Paulo

M5G 1X8

Novartis Investigative Site, Toronto

M5G 1Z6

Novartis Investigative Site, Toronto

00165

Novartis Investigative Site, Roma

3015 CN

Novartis Investigative Site, Rotterdam

3075 EA

Novartis Investigative Site, Rotterdam

08035

Novartis Investigative Site, Barcelona

08950

Novartis Investigative Site, Esplugues de Llobregat

413 45

Novartis Investigative Site, Gothenburg

SM2 5PT

Novartis Investigative Site, Sutton

LS9 7TF

Novartis Investigative Site, Leeds