drugset / Trial / NCT00411528

Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer

NCT00411528

Phase 2 Completed 185 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.

Timeline

Start
2006-09
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2
Subject Patupilone Small molecule 8 mg/m2
Subject Patupilone Small molecule 10 mg/m2
Background Prednisone Other / unclassified 5 mg