drugset / Trial / NCT00663832

A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer

NCT00663832

Phase 1 Completed 44 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.

Timeline

Start
2008-02
Primary completion
2011-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Panobinostat Small molecule 10 mg/m2 Intravenous
Subject Panobinostat Small molecule 15 mg/m2 Intravenous
Subject Panobinostat Small molecule 20 mg/m2 Intravenous
Background Docetaxel Small molecule 60 mg/m2 Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Prednisone Other / unclassified 5 mg Oral

Indications