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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2012

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.
  • Other: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.

Clinical Trial Outcome Measures

Primary 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
    • 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 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ipsen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ipsen Medical Director, Study Director, Ipsen

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.