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COMPLETED Phase 3

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

NCT01188187 · View on ClinicalTrials.gov ↗

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

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

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01188187

The ClinicalTrials.gov registry entry for NCT01188187 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,022 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Achieve Life Sciences, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01188187 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01188187?

The interventions under investigation include: Docetaxel (DRUG), Dexamethasone (DRUG), Prednisone (DRUG), Custirsen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01188187?

This trial is sponsored by Achieve Life Sciences, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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