Clinical Trial Details
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
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
|Pediatrics Academic Administration|
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.
|201304508 ; cancer ; medulloblastoma ; O ; pediatric ; Phase three ; |