NCT00571675

A Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Ascenta Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic hormone-refractory prostate cancer, who have received hormonal therapy but not chemotherapy.

Detailed description

Further Study Details provided by Ascenta.

Conditions

• Hormone Refractory Prostate Cancer

Interventions

Type	Name	Description
DRUG	AT-101, prednisone and docetaxel	docetaxel (75mg/m2 intravenously over 1 hour on day 1, every 21 days \[one cycle\]), oral prednisone (5mg BID on days 1-21), and oral AT-101 on cycle days 1-3
DRUG	placebo, prednisone and docetaxel	docetaxel (75mg/m2 intravenously over 1 hour every 21 days \[one cycle\]), oral prednisone (5mg BID on days 1-21), and oral placebo on cycle days 1-3

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2007-12-12
• Last updated: 2010-11-09

Locations

35 sites across 2 countries: United States, Russia