Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
Information source: Ipsen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Ipsen Official(s) and/or principal investigator(s): Martin Gerwe, MD, Study Director, Affiliation: Ipsen
Summary
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin
pamoate (Pamorelin® LA 11. 25 mg), applied either IM or SC, in terms of the area under the
curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.
Clinical Details
Official title: A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
Secondary outcome: Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d) Maximum Concentration of Serum Testosterone [Cmax] - Raw Data Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Histologically or cytologically proven prostate cancer, locally advanced or
metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and
the patient scheduled to receive androgen deprivation therapy
- Serum testosterone levels ≥ 125 ng/dl (1. 25 ng/ml, 1. 25 microg/l, 4. 3 nmol/l)
measured by any laboratory or on site within the previous 6 months or at study start
- Karnofsky performance index > 70
- Expected survival ≥ 9 months
Exclusion Criteria:
- Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone
(GnRH) agonists or antagonists within the last 12 months preceding the study or
concomitant treatment with one or more of these substance(s)
- Any current use or within 6 months prior to treatment start of medications which are
known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole,
aminoglutethimide, oestrogens and progesterone
- Patient at risk of spinal cord compression or ureter obstruction
- Prior hypophysectomy or adrenalectomy
Locations and Contacts
Kreiskrankenhaus, Abteilung Urologie, Bad Bergzabern 76887, Germany
Praxis für Urologie, Bad Ems, Germany
Praxis für Urologie, Bamberg 96047, Germany
Praxis für Urologie, Berlin, Germany
Praxis für Urologie, Braunschweig, Germany
Praxis für Urologie, Cham, Germany
Praxis für Urologie, Chemnitz, Germany
Praxis für Urologie, Dessau, Germany
Loretto Krankenhaus, Abteilung Urologie, Freiburg 79100, Germany
Praxis für Urologie, Gelsenkirchen, Germany
Praxis für Urologie, Herzberg, Germany
Praxis für Urologie, Lutherstadt Eisleben, Germany
Praxis für Urologie, Marburg, Germany
Praxis für Urologie, Markkleeberg, Germany
Praxis für Urologie, Miltenberg, Germany
Praxis für Urologie, Mülheim, Germany
Praxis für Urologie, München 81241, Germany
Praxis für Urologie, Neunkirchen, Germany
Urologische Klinik, Neunkirchen, Germany
Praxis für Urologie, Reutlingen 72764, Germany
Praxis für Urologie, Wesel, Germany
Praxis für Urologie, Wuppertal, Germany
Additional Information
Starting date: December 2010
Last updated: April 30, 2014
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