A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases (ENTHUSE M1)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Placebo; Drug: ZD4054

Study type: Interventional

Funder types: Industry

Identifiers

NCT00554229

D4320C00014

2007-003227-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 896 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who answer TRUE to the following criteria may be eligible to participate in this trial.

1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)
2. Increasing Prostate Specific Antigen (PSA) over a one month period
3. No pain, or mild pain from prostate cancer
4. 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.

1. Currently using opiates based pain killers)
2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
3. Suffering from heart failure or had a myocardial infarction within last 6 months
4. A history of epilepsy or seizures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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896 participants in 2 patient groups, including a placebo group

ZD4054

Experimental group

Description:

ZD4054 10 mg oral tablet once daily

Treatment:

Drug: ZD4054

Placebo

Placebo Comparator group

Description:

Matching Placebo, oral tablets once daily

Treatment:

Drug: Placebo