Phase 3
Completed N=594
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
Source: ClinicalTrials.gov NCT00554229 ↗Enrolled (actual)
594
Serious AEs
34.2%
Results posted
May 2012
Primary outcomePrimary: Overall Survival — 24.5; 22.5 months
Summary
Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.
* This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
* ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.
* All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy.
* Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
* No patients will be deprived of standard prostate cancer therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
24.5; 22.5 | — |
| SECONDARY Progression Free Survival |
6.2; 6.5 | — |
| SECONDARY Time to Use of Opiates |
16.7; 14.8 | — |
| SECONDARY Incidence of Skeletal Related Events |
18.4; 17.1 | — |
| SECONDARY Bone Metastases Formation |
15.1; 11.9 | — |
| SECONDARY Health Related Quality of Life |
5.5; 5.5 | — |
| SECONDARY Time to Prostate-specific Antigen (PSA) Progression |
5.6; 5.6 | — |
| SECONDARY Time to Pain Progression |
9.0; 8.4 | — |
| SECONDARY Time to Initiation of Chemotherapy |
11.4; 10.6 | — |
| SECONDARY Pharmacokinetic Characteristics of ZD4054 |
— | — |
Eligibility Criteria
Inclusion Criteria
Patients who answer TRUE to the following criteria may be eligible to participate in this trial.
- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)
- Increasing Prostate Specific Antigen (PSA) over a one month period
- No pain, or mild pain from prostate cancer
- Currently receiving treatment with surgical or medical castration
Exclusion Criteria
Patients who answer TRUE to the following may NOT eligible to participate in this trial.
- Currently using opiates based pain killers)
- Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
- Suffering from heart failure or had a myocardial infarction within last 6 months
- A history of epilepsy or seizures
Data sourced from ClinicalTrials.gov (NCT00554229). 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.