A Phase I Dose Finding and Safety Study of Oral LDE225 in Children and a Phase II Portion to Assess Preliminary Efficacy in Recurrent or Refractory MB

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
MedulloblastomaRhabdomyosarcomaNeuroblastomaHepatoblastomaGliomaAstrocytoma
Interventions
DRUG

LDE225

LDE225/sonidegib capsules were supplied to the Investigators at dose strengths of 50 mg, 100 mg, 200 mg, and 250 mg.

Trial Locations (14)

3052

Novartis Investigative Site, Parkville

20133

Novartis Investigative Site, Milan

21231

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

30342

Children's Healthcare of Atlanta Childern Hosp - ATL, Atlanta

40139

Novartis Investigative Site, Bologna

75231

Novartis Investigative Site, Paris

94805

Novartis Investigative Site, Villejuif

98105

Seattle Children's Hospital CPKC412A2114, Seattle

02115

Dana Farber Cancer Institute DFCI (3), Boston

M5G 1X8

Novartis Investigative Site, Toronto

M5G 2M9

Novartis Investigative Site, Toronto

00168

Novartis Investigative Site, Roma

SM2 5PT

Novartis Investigative Site, Sutton

NE1 4LP

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY