A Phase III, Randomised, Double-Blind, Placebo-Controlled Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer (TasQ003)

NCT02057666 Phase 3 TERMINATED Results posted

The primary objective was to confirm the effect of tasquinimod in delaying disease progression or death as compared with placebo in chemo-naïve patients with metastatic castrate-resistant prostate cancer (mCRPC). Secondary objectives included further evaluation of the safety profile of tasquinimod, comparison of clinical benefits (such as overall survival and symptoms) of tasquinimod with placebo, to evaluate the quality of life impact and to determine the pharmacokinetics of tasquinimod.

Details

Lead sponsor	Ipsen
Phase	Phase 3
Status	TERMINATED
Enrolment	146
Start date	2014-01
Completion	2015-05

Conditions

• Prostatic Neoplasms, Castration-Resistant

Interventions

• Tasquinimod
• Placebo

Primary outcomes

• Time to Radiological Progression-Free Survival (PFS) — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
  PFS was defined as the time from the date of randomisation to the date of radiological progression (confirmed by the central imaging assessment) or death due to any cause. Radiological progression was defined by any of the following criteria: progression of soft tissue lesions evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 criteria; progression of bone lesions detected with bone scan according to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria; or radiologically confirmed spinal cord compression or pathological fracture due to malignant progression. The primary endpoint was centrally and independently evaluated.

Countries

China, South Korea, Taiwan