At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
ZD4054 10 mg +2 moredrug
Likely dose
ZD4054 10 mg, 15 mg, or 22.5 mg orally once dailyAI-extracted
Key inclusion· 2
- ✓Men 18 years or older
- ✓Confirmed diagnosis of prostate cancer with bone metastases
Key exclusion· 1
- ✕More than 2 prior chemotherapy regimens
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ZD4054 10 mg, ZD4054 15 mg, and 1 other intervention for Prostatic Neoplasms and Metastases, Neoplasm. Completed, enrolled 22 participants across 2 sites.
Detailed Summary
The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms, Metastases, Neoplasm
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2003
Enrollment StartJun 2003
Primary CompletionOct 2005
TodayJul 2026
First PostedMar 4, 2003
Enrollment StartJun 1, 2003
Primary CompletionOct 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 23.3 years ago
Interventions
ZD4054 10 mgdrug
1 x 10 mg oral tablets once daily
ZD4054 15 mgdrug
1 x 10 mg + 2 x 2.5 mg oral tablets once daily
ZD4054 22.5 mgdrug
2 x 10 mg + 2 x 2.5 mg oral tablets once daily