Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

Overview

The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in: – achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days after investigational medicinal product (IMP) injection], and – in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.

Full Title of Study: “A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2013

Interventions

  • Drug: Triptorelin embonate 22.5 mg

Arms, Groups and Cohorts

  • Experimental: Triptorelin embonate 22.5 mg
    • Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
    • Time Frame: within 337 days

Secondary Measures

  • Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169
    • Time Frame: on Days 1 and 169
  • Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
    • Time Frame: Baseline through Day 337
  • Number of Participants Who Presented a Real “Acute-on-chronic” (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)
    • Time Frame: Day 171
  • Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)
    • Time Frame: Days 1-169
  • Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)
    • Time Frame: Days 1-169
  • Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)
    • Time Frame: Days 1-169
  • Testosterone PD Metrics for First Injection: Time to Castration (Tcast)
    • Time Frame: Days 1-169
  • Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)
    • Time Frame: Days 1-169 and Days 169-337
  • Triptorelin PK Metrics for Both Injections: Cmax
    • Time Frame: Days 1-169 and Days 169-337
  • Triptorelin PK Metrics for Both Injections: Concentration 0 Hour
    • Time Frame: Days 1-169 and Days 169-337

Participating in This Clinical Trial

Summary Inclusion Criteria:

  • Meets protocol-specified criteria for qualification and contraception – Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications – Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures Summary Exclusion Criteria:

  • Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters – Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results

Gender Eligibility: Male

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Debiopharm International SA
  • Collaborator
    • Quintiles, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eija Lundstrom, MD, Study Director, Debiopharm SA
    • J. Bahlmann, MD, Principal Investigator, Private Practitioner

References

Klippel KF, Winkler CJ, Jocham D, Rubben H, Moser B, Gulati A. [Effectiveness and tolerance of 1 dosage forms (subcutaneous and intramuscular) of decapeptyl depot in patients with advanced prostate carcinoma]. Urologe A. 1999 May;38(3):270-5. doi: 10.1007/s001200050280. German.

Tornoe CW, Agerso H, Senderovitz T, Nielsen HA, Madsen H, Karlsson MO, Jonsson EN. Population pharmacokinetic/pharmacodynamic (PK/PD) modelling of the hypothalamic-pituitary-gonadal axis following treatment with GnRH analogues. Br J Clin Pharmacol. 2007 Jun;63(6):648-64. doi: 10.1111/j.1365-2125.2006.02820.x. Epub 2006 Nov 10.

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