UI Hospitals and Clinics

Clinical Trial Details

Short Title
Oral LDE225 Versus Temozolomide in Patients With Hh-pathway Activated Relapsed Medulloblastoma
Official Title

A Phase III, Multi-center, Open-label, Randomized, Controlled Study of the Efficacy and Safety of Oral LDE225 Versus Temozolomide in Patients With Hh-pathway Activated Relapsed Medulloblastoma

Description

Participants in this research study have relapsed medulloblastoma and will receive the drug LDE225 or Temozolomide. The purpose of the study is to find out if the drug LDE225 is safe and has more beneficial effects in people who have relapsed medulloblastoma compared to the drug Temozolomide. LDE225 is an investigational drug being developed by Novartis, the Sponsor, for the treatment of cancer. Temozolomide is a medication that is indicated for the treatment of patients with certain brain tumors.

About 109 patients from about 89 sites in North America, Europe, Australia and Latin America will be enrolled into this study.

Start Date
December 12, 2013
End Date
January 1, 2018
Gender Preference
None
Age Group
0 - 99 years
Principal Investigator
Sue O'Dorisio, MD, PhD
Contact Info

Joan Kempf, (319) 384-5280

Department
Pediatrics Academic Administration
Keywords
201304508 ; cancer ; medulloblastoma ; O ; pediatric ; Phase three ;

We welcome your feedback! Please help us improve your experience on our website by completing a brief survey.