A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2007 |
| End Date: | August 2011 |
A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.
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.
(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.
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
We found this trial at
20
sites
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