Phase 2
Completed N=16
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
Prostate Cancer · Metastases, Neoplasm
Source: ClinicalTrials.gov NCT00055471 ↗
Enrolled (actual)
16
Serious AEs
25.0%
Results posted
Aug 2012
Primary outcomePrimary: Dose Limiting Toxicities (DLTs) — 0; 0; 2 Participants
Summary
The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicities (DLTs) |
0; 0; 2 | — |
| SECONDARY Total Prostate Specific Antigen (PSA) Concentration |
98.454; 62.366; 56.550 | — |
| SECONDARY Change in Total Prostate Specific Antigen (PSA) |
2.235; 10.986; 18.404 | — |
| SECONDARY Change in Serum Concentration of Bone Alkaline Phosphatase (ALP) |
-6.161; -9.197; -9.182 | — |
| SECONDARY Change in Serum Concentration of Procollagen Type I N Propeptide (PINP) |
7.865; 20.681; 113.012 | — |
| SECONDARY Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx) |
-13.832; 44.855; 20.386 | — |
| SECONDARY Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) |
-25.213; 2.154; -5.942 | — |
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
Data sourced from ClinicalTrials.gov (NCT00055471). 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. Informational only — not medical advice.