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NCT00626548 · ClinicalTrials.gov registry record · Phase 3
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
A Phase 3 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2,577
- Enrollment target
NCT00626548: Clinical Trial Phase 3 study, sponsored by AstraZeneca.
NCT00626548 is a Phase 3 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 2,577 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (234% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00626548, a Phase 3 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2,577 participants
- Enrollment target
Study Summary
Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments. ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases. All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy. Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour. No patients will be deprived of standard prostate cancer therapy.
Primary Outcome
Number of participants who have died at early analysis data cut off (DCO)
Interventions
- DRUG ZD4054
- DRUG Palcebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,577 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
Why NCT00626548 stopped before completion
NCT00626548 is an interventional study that assigns participants to a tested intervention. Its 2,577 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (234% higher).
The record links to 0 conditions, and to 2 interventions - of which ZD4054 is the first listed.
NCT00626548 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00626548 about?
NCT00626548 is a clinical study titled "A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer". Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a bac...
What is the current status of trial NCT00626548?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2,577 participants. The study started on 2008-01. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00626548?
The interventions under investigation include: ZD4054 (DRUG), Palcebo (DRUG).
Who is sponsoring clinical trial NCT00626548?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00626548's enrollment target sits among peer trials
2,577 85th of 2000 higher than 1,916 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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