At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 447 enrolled
Drug / intervention
ZD4054 15 mg +2 moredrug
Likely dose
ZD4054 15 mg orally once daily or 10 mg orally once dailyAI-extracted
Key inclusion· 3
- ✓Surgically or medically castrated
- ✓Bone metastasis present
- ✓Rising serum prostate-specific antigen (PSA)
Key exclusion· 2
- ✕Current opiate use
- ✕Prior chemotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
In Brief
A Phase 2 clinical trial evaluating ZD4054 15 mg, Placebo, and 1 other intervention for Prostate Cancer. Completed, enrolled 447 participants across 60 sites in 14 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesAustralia, Belgium, Canada, Denmark, Finland, France, Indonesia, Netherlands, Norway, Poland, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2004
First PostedAug 2004
Primary CompletionDec 2008
Study CompletionAug 2011
TodayJul 2026
First PostedAug 30, 2004
Enrollment StartJul 1, 2004
Primary CompletionDec 1, 2008
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 21.8 years ago
Interventions
ZD4054 15 mgdrug
15 mg oral tablet once daily
Placebodrug
ZD4054 10 mgdrug
10mg oral tablet once daily