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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00055471 |
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Date of registration:
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03/03/2003 |
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Primary sponsor: |
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Public title:
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A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer
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Scientific title:
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Date of first enrolment:
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June 2003 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00055471 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men 18 years & older
- Confirmed diagnosis of prostate cancer with bone metastases
Exclusion Criteria:
- No more than 2 prior chemotherapy regimens
- No radiation, chemotherapy or bisphosphonates in the past 4 weeks
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Metastases, Neoplasm
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Prostatic Neoplasms
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Intervention(s)
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Drug: ZD4054 10 mg
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Drug: ZD4054 15 mg
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Drug: ZD4054 22.5 mg
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Primary Outcome(s)
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Dose Limiting Toxicities (DLTs)
[Time Frame: Baseline to Day 29.]
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Secondary Outcome(s)
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Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)
[Time Frame: Baseline to Day 15.]
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Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)
[Time Frame: Baseline to Day 15.]
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Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)
[Time Frame: Baseline to Day 15.]
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Change in Total Prostate Specific Antigen (PSA)
[Time Frame: Baseline to Day 15.]
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Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)
[Time Frame: Baseline to Day 15.]
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Total Prostate Specific Antigen (PSA) Concentration
[Time Frame: Baseline to Day 15.]
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Secondary ID(s)
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4054IL/0004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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