Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg

Prostate Cancer Clinical Trial

— PAMIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257425
• Other study ID #: A-94-52014-178
• Secondary ID: 2010-019632-12
• Status: Completed
• Phase: Phase 2
• Start date: December 2010
• Est. completion date: May 2012

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85. Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.

Locations

Country	Name	City	State
Germany	Kreiskrankenhaus, Abteilung Urologie	Bad Bergzabern
Germany	Praxis für Urologie	Bad Ems
Germany	Praxis für Urologie	Bamberg
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
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
Germany	Praxis für Urologie	Neunkirchen
Germany	Urologische Klinik	Neunkirchen
Germany	Praxis für Urologie	Reutlingen
Germany	Praxis für Urologie	Wesel
Germany	Praxis für Urologie	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).	Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.	1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose
Secondary	Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)	Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.	1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Secondary	Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)	Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.	85, 87, 113, 141 and 169 days post-dose
Secondary	Maximum Concentration of Serum Testosterone [Cmax] - Raw Data	Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.	1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Secondary	Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data	Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.	1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Secondary	Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL	tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.	12 weeks
Secondary	Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL	tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.	12 weeks