Phase 2
N=312
ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00090363 ↗Enrolled (actual)
312
Serious AEs
19.2%
Results posted
Sep 2012
Primary outcome: Primary: Time to Progression (TTP) — 111; 138; 113 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ZD4054 15 mg (Drug); Placebo (Drug); ZD4054 10 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) |
111; 138; 113 | — |
| SECONDARY Time to Death |
596; 706; 717 | — |
| SECONDARY Change in Total Prostate Specific Antigen (PSA) Over Time |
110.4; 131.6; 69.34 | — |
| SECONDARY Objective Response Rate (ORR) |
0; 0; 0 | — |
| SECONDARY Change in Number of Bone Metastases Over Time |
187.1; 113.4; 189 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Surgically or medically castrated
- Bone metastasis
- Rising PSA
Exclusion Criteria
- Opiate use
- Prior chemotherapy
Data sourced from ClinicalTrials.gov (NCT00090363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.