drugset / Trial / NCT02182622

LDE225 + Docetaxel/Prednisone for Adv/Met Castrate Resistant Prostate Cancer w/ Disease Progression After Docetaxel

NCT02182622

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to first determine the highest dose of LDE225 combined wtih Docetaxel and Prednisone that can be given that does not cause unacceptable side effects when given to patients with castrate resistant prostate cancer who failed previous docetaxel therapy.

Timeline

Start
2014-07
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 60 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Sonidegib Small molecule 200 mg Oral
Subject Sonidegib Small molecule 400 mg Oral
Subject Sonidegib Small molecule 800 mg Oral
Background Prednisone Other / unclassified 5 mg Oral

Indications