View Clinical Trial (Medical Research Study)
A Phase III Trial of ZD4054 (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer - NCT00626548-(Clinical Trial 206296)
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Milwaukee |
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WI |
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| Conditions: |
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Prostate Cancer |
| Purpose: |
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Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan)
in hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan)
can improve progression-free survival and overall survival against a background of existing
prostate cancer treatments.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and
spread by blocking Endothelin receptor activity. This trial will look at the effects of
ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had
rising PSA after surgical or medical castration but have no evidence of metastases.
All patients participating in this clinical trial will receive existing 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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
Patients who answer TRUE to the following criteria may be eligible to participate in this
study.
- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT
spread to the other parts of the body (metastases). Patients with lymph node
involvement may be eligible if specified criteria is met.
- 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 may NOT be eligible to participate in this
study.
- Currently using opiate based pain killers for cancer related pain
- 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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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September 22, 2010 |
Modifications to
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above to view all information about this clinical trial. |
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