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

NCT01234311 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1245

Last updated 2015-10-21

No results posted yet for this study

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).

Conditions

Interventions

DRUG

tasquinimod

Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)

DRUG

Placebo

Sponsors & Collaborators

  • Active Biotech AB

    lead INDUSTRY

Principal Investigators

  • Michael A Carducci, MD · Johns Hopkins Kimmel Cancer Center, Baltimore, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-02-28
Completion
2015-08-31

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

Study Locations

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Entities

Drugs
Diseases

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 NCT01234311 on ClinicalTrials.gov