A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
Public ClinicalTrials.gov record NCT00617669. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00617669
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,494 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2008 (Type not available)
- Primary completion
- May 2011 (Actual)
- Completion
- Jul 2011 (Actual)
- Last update posted
- Sep 10, 2012
2008 – 2011
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Greenbrae | California | — | — |
| Research Site | San Diego | California | — | — |
| Research Site | Norwich | Connecticut | — | — |
| Research Site | Washington D.C. | District of Columbia | — | — |
| Research Site | Fort Myers | Florida | — | — |
| Research Site | Gainsville | Florida | — | — |
| Research Site | Ocala | Florida | — | — |
| Research Site | PORTUGALt Saint Lucie | Florida | — | — |
| Research Site | Rockville | Maryland | — | — |
| Research Site | Minneapolis | Minnesota | — | — |
| Research Site | Lincoln | Nebraska | — | — |
| Research Site | Omaha | Nebraska | — | — |
| Research Site | Chapel Hill | North Carolina | — | — |
| Research Site | Durham | North Carolina | — | — |
| Research Site | Winston-Salem | North Carolina | — | — |
| Research Site | Canton | Ohio | — | — |
| Research Site | Cincinnati | Ohio | — | — |
| Research Site | Pittsburgh | Pennsylvania | — | — |
| Research Site | Charleston | South Carolina | — | — |
| Research Site | Chattanooga | Tennessee | — | — |
| Research Site | Nashville | Tennessee | — | — |
| Research Site | San Antonio | Texas | — | — |
| Research Site | Richmond | Virginia | — | — |
| Research Site | Seattle | Washington | — | — |
| Research Site | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 122 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00617669, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 10, 2012 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00617669 live on ClinicalTrials.gov.