A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer (ENTHUSE M1C)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Docetaxel; Drug: ZD4054; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00617669

D4320C00033

Details and patient eligibility

About

Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.

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 compared with docetaxel.

All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.

Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.

Enrollment: 1,494 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.

• Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)
• Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
• Currently receiving treatment with surgical or medical castration

Exclusion criteria

Patients who answer TRUE to the following ARE NOT eligible to participate in this trial.

• Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial.
• Suffering from heart failure or had a myocardial infarction within last 6 months
• A history of epilepsy or seizures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,494 participants in 2 patient groups

Placebo + Docetaxel

Active Comparator group

Description:

placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Treatment:

Drug: Placebo

Drug: Docetaxel

ZD4054 + Docetaxel

Experimental group

Description:

ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Treatment:

Drug: ZD4054

Drug: Docetaxel