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

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00554229

Run by

AstraZeneca

People needed

896

Starts

2007-11-01

Expected to finish

2011-08-01

Last updated by the study team

2016-02-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Greenbrae, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Palm Springs, California, United States
• Research Site — San Mateo, California, United States
• Research Site — Norwich, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Gainsville, Florida, United States
• Research Site — Port St.Lucie, Florida, United States
• Research Site — Des Moines, Iowa, United States
• Research Site — Canton, Ohio, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Salt Lake City, Utah, United States
• Research Site — Burlington, Vermont, United States
• Research Site — Norfolk, Virginia, United States
• Research Site — Seattle, Washington, United States
• Research Site — Wheeling, West Virginia, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — Buenos Aires, Buenos Aires, Argentina
• Research Site — Santa Fe, Santa Fe Province, Argentina
• Research Site — Hornsby, New South Wales, Australia
• Research Site — St Leonards, New South Wales, Australia
• Research Site — Redcliffe, Queensland, Australia
• Research Site — Ashford, South Australia, Australia
• Research Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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