A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally... | NCT00055471 | Trialant
CompletedInterventionalPhase 2Updated Oct 31, 2012
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
ClinicalTrials.gov ID
NCT00055471
Lead Sponsor
AstraZenecaINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
22Actual
Last Update Posted
Oct 31, 2012Estimated
Start Date
Jun 2003
Primary Completion Date
Oct 2005Actual
Completion Date
Oct 2005Actual
Brief Summary
The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer
Prostatic Neoplasms
Metastases, Neoplasm
ZD4054 10 mg
ZD4054 15 mg
ZD4054 22.5 mg
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men 18 years & older
Confirmed diagnosis of prostate cancer with bone metastases
Exclusion Criteria:
No more than 2 prior chemotherapy regimens
No radiation, chemotherapy or bisphosphonates in the past 4 weeks