MedTrace Logo

Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer

NCT02057666 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2021-04-23

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Prostatic Neoplasms, Castration-Resistant

Interventions

DRUG

Tasquinimod

A patient initially received a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively.

DRUG

Placebo

Placebo capsules were identical to tasquinimod capsules in appearance and excipients but excluded the active compound (tasquinimod).

Sponsors & Collaborators

Principal Investigators

  • Medical Director Uro-Oncology · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • China
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02057666 on ClinicalTrials.gov