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NCT01188187 · ClinicalTrials.gov registry record · Phase 3

Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer

A Phase 3 study of Prostate Cancer, sponsored by Achieve Life Sciences.

Completed
Registry status
Phase 3
Development phase
1,022
Enrollment target
20
Study locations

NCT01188187 is a Phase 3 study of Prostate Cancer that has completed, run by Achieve Life Sciences. The registered enrollment target is 1,022 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (68% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT01188187, a Phase 3 study of Prostate Cancer, has completed, sponsored by Achieve Life Sciences.

COMPLETED
Registry status
Phase 3
Development phase
1,022 participants
Enrollment target
20
Study locations

Study Summary

This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms.

Conditions Studied

Prostate Cancer

Interventions

  • DRUG Docetaxel
  • DRUG Dexamethasone
  • DRUG Prednisone
  • DRUG Custirsen

Study Locations (20)

California

  • Teva Investigational Site 086 - Los Angeles
  • Teva Investigational Site 263 - Los Angeles
  • Teva Investigational Site 093 - Marina del Rey
  • Teva Investigational Site 097 - San Diego

Florida

  • Teva Investigational Site 106 - Fort Myers
  • Teva Investigational Site 094 - Port Saint Lucie

Michigan

  • Teva Investigational Site 098 - Ann Arbor
  • Teva Investigational Site 112 - Detroit

South Carolina

  • Teva Investigational Site 266 - Greensboro
  • Teva Investigational Site 102 - Myrtle Beach

Tennessee

  • Teva Investigational Site 084 - Memphis
  • Teva Investigational Site 101 - Nashville

Alabama

  • Teva Investigational Site 100 - Birmingham

Colorado

  • Teva Investigational Site 090 - Fort Collins

Georgia

  • Teva Investigational Site 096 - Atlanta

Trial Details

FieldValue
Enrollment Target 1,022 participants
Start Date 2010-11
Est. Completion 2014-06
Phase Phase 3

Sponsor

Achieve Life Sciences

17 total trials

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What the Registry Record Tells You About NCT01188187

The ClinicalTrials.gov registry entry for NCT01188187 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,022 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 (68% higher). The listed sponsor is Achieve Life Sciences, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.

NCT01188187 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Michigan.

Frequently Asked Questions

What is clinical trial NCT01188187 about?

NCT01188187 is a clinical study titled "Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer". This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicente...

What is the current status of trial NCT01188187?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,022 participants. The study started on 2010-11. Estimated completion is 2014-06.

What conditions does trial NCT01188187 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT01188187?

The interventions under investigation include: Docetaxel (DRUG), Dexamethasone (DRUG), Prednisone (DRUG), Custirsen (DRUG).

Who is sponsoring clinical trial NCT01188187?

This trial is sponsored by Achieve Life Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01188187 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. 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.