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OpenTrials
Completed

NCT Number: NCT01656161

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Vergelegen Medi-Clinic, Somerset West, Cape Town, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triptorelin embonate 22.5 mg

Drug

Other names: Pamorelin

Primary outcomes

  1. Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)

    Time frame: within 337 days

Secondary outcomes

  1. 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

  2. Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337

    Time frame: Baseline through Day 337

  3. 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

  4. Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)

    Time frame: Days 1-169

  5. Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)

    Time frame: Days 1-169

  6. Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)

    Time frame: Days 1-169

  7. Testosterone PD Metrics for First Injection: Time to Castration (Tcast)

    Time frame: Days 1-169

  8. Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)

    Time frame: Days 1-169 and Days 169-337

  9. Triptorelin PK Metrics for Both Injections: Cmax

    Time frame: Days 1-169 and Days 169-337

  10. Triptorelin PK Metrics for Both Injections: Concentration 0 Hour

    Time frame: Days 1-169 and Days 169-337

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 2, 2012
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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