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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01257425
First received: December 8, 2010
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d). [ Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d) [ Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose ] [ Designated as safety issue: No ]
    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.

  • Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d) [ Time Frame: 85, 87, 113, 141 and 169 days post-dose ] [ Designated as safety issue: No ]
    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.

  • Maximum Concentration of Serum Testosterone [Cmax] - Raw Data [ Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose ] [ Designated as safety issue: No ]
    Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.

  • Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data [ Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose ] [ Designated as safety issue: No ]
    Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.

  • Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 109
Study Start Date: December 2010
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM. 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.

Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. 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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257425

Locations
Germany
Kreiskrankenhaus, Abteilung Urologie
Bad Bergzabern, Germany, 76887
Praxis für Urologie
Bad Ems, Germany
Praxis für Urologie
Bamberg, Germany, 96047
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, 79100
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, 81241
Praxis für Urologie
Neunkirchen, Germany
Urologische Klinik
Neunkirchen, Germany
Praxis für Urologie
Reutlingen, Germany, 72764
Praxis für Urologie
Wesel, Germany
Praxis für Urologie
Wuppertal, Germany
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Martin Gerwe, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01257425     History of Changes
Other Study ID Numbers: A-94-52014-178, 2010-019632-12
Study First Received: December 8, 2010
Results First Received: September 27, 2013
Last Updated: April 30, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014