Trial intelligence / Profile preview

Tasquinimod in Asian mCRPC

NCT02057666Phase 3

Key facts

Status: Terminated
Start: Jan 2014
Primary completion: May 2015
Countries: 3
Sponsor: Ipsen
Modality: Small Molecules

Drugs: tasquinimod
Conditions: metastatic castration-resistant prostate cancer (mCRPC)

Overview

Phase 3, randomised, double-blind trial in metastatic castration-resistant prostate cancer (mCRPC) comparing Tasquinimod with Placebo (2 arms). Primary endpoint: Time to Radiological Progression-Free Survival up to 3 years. Started Jan 2014; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Tasquinimod
Tasquinimod 0.25 mg/day titrated to 1 mg/day
Placebo
Placebo matching Tasquinimod

Endpoints

Primary

Time to Radiological Progression-Free Survivalup to 3 years

Secondary

Overall Survivalup to 3 years
Local Assessment of Radiological PFSup to 3 years
Time to Symptomatic PFS Based on Local AssessmentEvery 3 months
Time From Randomisation to Further Treatment for Prostate CancerEvery 6 months
Quality of LifeEvery 3 months
Tasquinimod Pharmacokinetic ProfileDay 127

Results

Primary endpoints met

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