Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00090363 · ClinicalTrials.gov registry record · Phase 2

ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)

A Phase 2 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
447
Enrollment target

NCT00090363: Completed Phase 2 study, sponsored by AstraZeneca.

NCT00090363 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 447 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (236% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00090363, a Phase 2 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
447 participants
Enrollment target

Study Summary

This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).

Primary Outcome

Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.

Interventions

  • DRUG Placebo
  • DRUG ZD4054 10 mg
  • DRUG ZD4054 15 mg

Trial Details

FieldValue
Enrollment Target 447 participants
Start Date 2004-07
Est. Completion 2011-08
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT00090363 record still lists

NCT00090363 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (236% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00090363 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00090363 about?

NCT00090363 is a clinical study titled "ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)". This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).

What is the current status of trial NCT00090363?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 447 participants. The study started on 2004-07. Estimated completion is 2011-08.

What interventions are being tested in trial NCT00090363?

The interventions under investigation include: Placebo (DRUG), ZD4054 10 mg (DRUG), ZD4054 15 mg (DRUG).

Who is sponsoring clinical trial NCT00090363?

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

How this trial's enrollment target compares

Where NCT00090363's enrollment target sits among peer trials

447 89th of 2000 higher than 1,912 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04065399 · 447 participants · Phase 1

    A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

  • NCT06702449 · 448 participants · Phase 1

    A Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age

  • NCT07125053 · 448 participants · NA

    COPD Resources, Education, and Activity Designed for You Study

  • NCT01280994 · 445 participants · Phase 2

    Hyperpolarized 129Xe MRI for Imaging Pulmonary Function

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00090363, the US trial registry maintained by the National Library of Medicine. NCT00090363 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.