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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: Completed Phase 3 study of Prostate Cancer, sponsored by AstraZeneca.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Median time (in months) from randomisation until death using the Kaplan-Meier method.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,494 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00617669 record still lists
NCT00617669 is an interventional study that assigns participants to a tested intervention. Its 1,494 participants enrollment target places it among the larger protocols in the corpus, above the 606-participant average among 735 other Prostate Cancer trials with a reported enrollment target (147% higher).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00617669's enrollment target sits among peer trials
1,494 38th of 735 higher than 698 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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