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

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

The primary endpoint is progression-free survival (PFS) defined as the time from the date of randomization to the date of radiological progression or death.

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
Active Biotech AB

4 total trials

What the finished NCT01234311 record still lists

NCT01234311 is an interventional study that assigns participants to a tested intervention. Its 1,245 participants enrollment target places it among the larger protocols in the corpus, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (105% higher).

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 names 20 study sites across 14 states, led by 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.

Learn More About Clinical Trials

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01234311's enrollment target sits among peer trials

1,245 42nd of 735 higher than 694 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01234311, the US trial registry maintained by the National Library of Medicine. NCT01234311 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.