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NCT01234311 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Prostate Cancer, sponsored by Active Biotech AB.

Completed
Registry status
Phase 3
Development phase
1,245
Enrollment target
20
Study locations

NCT01234311 is a Phase 3 study of Prostate Cancer that has completed, run by Active Biotech AB. The registered enrollment target is 1,245 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (105% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT01234311, a Phase 3 study of Prostate Cancer, has completed, sponsored by Active Biotech AB.

COMPLETED
Registry status
Phase 3
Development phase
1,245 participants
Enrollment target
20
Study locations

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 Studied

Prostate Cancer

Interventions

  • DRUG Placebo
  • DRUG tasquinimod

Study Locations (20)

California

  • - Oxnard
  • - Santa Monica
  • - Santa Rosa

Illinois

  • - Melrose Park
  • - Park Ridge

Maryland

  • - Baltimore
  • - Rockville

New Jersey

  • - Hackensack
  • - Lawrenceville

New York

  • - Buffalo
  • - Poughkeepsie

Arizona

  • - Tucson

Florida

  • - Wellington

Georgia

  • - Atlanta

Trial Details

FieldValue
Enrollment Target 1,245 participants
Start Date 2011-03
Est. Completion 2015-08
Phase Phase 3

Sponsor

Active Biotech AB

4 total trials

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What the Registry Record Tells You About NCT01234311

The ClinicalTrials.gov registry entry for NCT01234311 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,245 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (105% higher). The listed sponsor is Active Biotech AB, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01234311 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Illinois, Maryland.

Frequently Asked Questions

What is clinical trial NCT01234311 about?

NCT01234311 is a clinical study titled "A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer". 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 CR...

What is the current status of trial NCT01234311?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,245 participants. The study started on 2011-03. Estimated completion is 2015-08.

What conditions does trial NCT01234311 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT01234311?

The interventions under investigation include: Placebo (DRUG), tasquinimod (DRUG).

Who is sponsoring clinical trial NCT01234311?

This trial is sponsored by Active Biotech AB, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01234311 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.