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NCT00055471 · ClinicalTrials.gov registry record · Phase 2
A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer
A Phase 2 study of Prostatic Neoplasms and Metastases, Neoplasm, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 2
- Study locations
NCT00055471: Completed Phase 2 study of Prostatic Neoplasms and Metastases, Neoplasm, sponsored by AstraZeneca.
NCT00055471 is a Phase 2 study of Prostatic Neoplasms and Metastases, Neoplasm that has completed, run by AstraZeneca. The registered enrollment target is 22 participants, below the 514-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00055471, a Phase 2 study of Prostatic Neoplasms and Metastases, Neoplasm, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer
Primary Outcome
DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported.
Conditions Studied
Interventions
- DRUG ZD4054 10 mg
- DRUG ZD4054 15 mg
- DRUG ZD4054 22.5 mg
Study Locations (2)
Ohio
- Research Site - Cleveland
Wisconsin
- Research Site - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2003-06 |
| Est. Completion | 2005-10 |
| Phase | Phase 2 |
What the finished NCT00055471 record still lists
NCT00055471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 514-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Prostatic Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which ZD4054 10 mg is the first listed.
NCT00055471 reports a single indexed study location in Ohio, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00055471 about?
NCT00055471 is a clinical study titled "A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer". The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer
What is the current status of trial NCT00055471?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2003-06. Estimated completion is 2005-10.
What conditions does trial NCT00055471 study?
This clinical trial studies the following conditions: Prostatic Neoplasms, Metastases, Neoplasm.
What interventions are being tested in trial NCT00055471?
The interventions under investigation include: ZD4054 10 mg (DRUG), ZD4054 15 mg (DRUG), ZD4054 22.5 mg (DRUG).
Who is sponsoring clinical trial NCT00055471?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00055471 being conducted?
This trial has 2 study locations across Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostatic Neoplasms
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 NCT00055471's enrollment target sits among peer trials
22 57th of 65 higher than 8 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms 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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