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Main
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Note: This record shows only 22 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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19 October 2017 |
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Main ID: |
NCT00686036 |
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Date of registration:
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27/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
ZENITH |
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Scientific title:
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A Randomized, Double-blind, Multicentre, Phase II Controlled Trial Assessing ZACTIMATM (Vandetanib) Against Placebo in Prolonging the Off-treatment Interval in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy |
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Date of first enrolment:
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May 2008 |
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Target sample size:
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17 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00686036 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Clinical Sciences & Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of prostate cancer
- Prostate specific antigen (PSA) greater than or equal to 5 ng/mL
- Recent completion of first hormone treatment [intermittent androgen deprivation with a
Luteinising hormone releasing hormone (LHRH) analogue]
- Screening PSA =1.0 ng/mL (within 6 weeks prior to study Day1)
Exclusion Criteria:
- Bone or soft tissue metastases
- Significant cardiovascular disease including hypertension not controlled by medical
therapy or history of irregular heart beats or recent heart attack
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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Prostate Cancer
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Intervention(s)
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Drug: vandetanib
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Drug: Placebo
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Primary Outcome(s)
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Number of Participants Not Reaching a PSA = 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)
[Time Frame: 52 weeks]
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Secondary Outcome(s)
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Percentage of Participants Not Reaching PSA = 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)
[Time Frame: 78 weeks during off-treatment phase of ADT]
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Serum Testosterone Levels
[Time Frame: Change from baseline at each visit post-randomization until until week 78]
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Time to PSA Progression (PSA = 5ng/mL and PSA = 10ng/mL)
[Time Frame: From the time o PSA rise from the date of randomization to both PSA = 5ng/mL and PSA = 10ng/mL]
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Secondary ID(s)
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D4200L00010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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