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NCT00617669 · ClinicalTrials.gov registry record · Phase 3

A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer

A Phase 3 study of Prostate Cancer, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
1,494
Enrollment target
20
Study locations

NCT00617669 is a Phase 3 study of Prostate Cancer that has completed, run by AstraZeneca. The registered enrollment target is 1,494 participants, above the 606-participant average among 735 other Prostate Cancer trials with a reported enrollment target (147% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT00617669, a Phase 3 study of Prostate Cancer, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
1,494 participants
Enrollment target
20
Study locations

Study Summary

Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone. ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel. All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies. Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour. No patients will be deprived of standard prostate cancer therapy.

Conditions Studied

Prostate Cancer

Interventions

  • DRUG Placebo
  • DRUG Docetaxel
  • DRUG ZD4054

Study Locations (20)

Florida

  • Research Site - Fort Myers
  • Research Site - Gainsville
  • Research Site - Ocala
  • Research Site - PORTUGALt Saint Lucie

North Carolina

  • Research Site - Chapel Hill
  • Research Site - Durham
  • Research Site - Winston-Salem

California

  • Research Site - Greenbrae
  • Research Site - San Diego

Nebraska

  • Research Site - Lincoln
  • Research Site - Omaha

Ohio

  • Research Site - Canton
  • Research Site - Cincinnati

Connecticut

  • Research Site - Norwich

District of Columbia

  • Research Site - Washington D.C.

Maryland

  • Research Site - Rockville

Trial Details

FieldValue
Enrollment Target 1,494 participants
Start Date 2008-01
Est. Completion 2011-07
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00617669

The ClinicalTrials.gov registry entry for NCT00617669 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,494 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 606-participant average among 735 other Prostate Cancer trials with a reported enrollment target (147% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00617669 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, North Carolina, California.

Frequently Asked Questions

What is clinical trial NCT00617669 about?

NCT00617669 is a clinical study titled "A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer". Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibote...

What is the current status of trial NCT00617669?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,494 participants. The study started on 2008-01. Estimated completion is 2011-07.

What conditions does trial NCT00617669 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT00617669?

The interventions under investigation include: Placebo (DRUG), Docetaxel (DRUG), ZD4054 (DRUG).

Who is sponsoring clinical trial NCT00617669?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00617669 being conducted?

This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Maryland. 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

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.