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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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16 December 2017 |
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Main ID: |
NCT02212197 |
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Date of registration:
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05/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
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Scientific title:
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A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 (Leuprolide Acetate FluidCrystal® Injection Depot Once Monthly) After Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients With Prostate Cancer |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02212197 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Finland
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Hungary
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Contacts
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Name:
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Teuvo Tammela, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tampere University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men =40 and =85 years of age
- Histological or cytological proven adenocarcinoma of the prostate requiring hormone
therapy
- Life expectancy over 12 months
- World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG)
performance status of 0, 1 or 2
- Adequate and stable renal function
- Adequate and stable hepatic function
Exclusion Criteria:
- Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction
- Serum Testosterone levels below 150 ng/dL at Screening visit
- Medical or radiological prostate cancer treatments within 2 months prior to the
Screening visit
- Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit
- Prior orchiectomy, hypophysectomy, or adrenalectomy
- Prior use of LHRH agonists within 12 months prior to the Screening visit and during
the study
Age minimum:
40 Years
Age maximum:
85 Years
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: leuprolide acetate FluidCrystal® injection depot
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Drug: leuprolide acetate
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Primary Outcome(s)
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Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3
[Time Frame: Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)]
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Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3
[Time Frame: 84 days]
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Apparent Terminal Half-life (t½) for Dose 1 and Dose 3
[Time Frame: Days 0-28 and Days 56-84]
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Secondary Outcome(s)
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Time (Days) to Testosterone Recovery After Dose 3
[Time Frame: Days 56-126]
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Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
[Time Frame: Days 0-126]
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Mean Prostate Specific Antigen (PSA) Concentration
[Time Frame: Days 0-126]
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Secondary ID(s)
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HS-12-460
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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