NCT01234311

A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,245 (actual)
• Sponsor: Active Biotech AB · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

Detailed description

This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	tasquinimod	Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)
DRUG	Placebo

Timeline

• Start date: 2011-03-01
• Primary completion: 2015-02-01
• Completion: 2015-08-01
• First posted: 2010-11-04
• Last updated: 2015-10-21

Locations

204 sites across 37 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Estonia, France, Germany, Greece, India, Israel, Italy, Latvia, Lebanon, Lithuania, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom