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

August 13, 2015 updated by: Debiopharm International SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Cape Town, South Africa, 7925
        • New Groote Schuur Hospital, Division of Urology
    • Cape Town
      • Somerset West, Cape Town, South Africa, 7130
        • Vergelegen Medi-Clinic
      • Tygerberg, Cape Town, South Africa, 7505
        • Department of Urology, Tygerberg Hospital
    • Cape Town, Western Cape
      • Paarl, Cape Town, Western Cape, South Africa, 7646
        • Paarl Medical Centre
    • Eastern Cape
      • George, Eastern Cape, South Africa, 6530
        • JCM Bahlmann
    • Gautang
      • Johannesburg, Gautang, South Africa, 1475
        • East Rand Urology Research Unit, Clinix Private Clinic
    • Gauteng
      • Kempton Park, Gauteng, South Africa, 1619
        • Clinresco Centres (Pty) Ltd
      • Pretoria, Gauteng, South Africa, 0002
        • Clinical Trial Unit, Room 2-54, Prinshof Medical Campus
      • Pretoria, Gauteng, South Africa, 0028
        • Pretoria Urology Hospital
    • North West Province
      • Klerksdorp, North West Province, South Africa, 2571
        • Wilmed Park Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Triptorelin embonate 22.5 mg
Other Names:
  • Pamorelin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
on Days 1 and 169
Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
Time Frame: Baseline through Day 337
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
Day 171
Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)
Time Frame: Days 1-169
Days 1-169
Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)
Time Frame: Days 1-169
Days 1-169
Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)
Time Frame: Days 1-169
Days 1-169
Testosterone PD Metrics for First Injection: Time to Castration (Tcast)
Time Frame: Days 1-169
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
Days 1-169 and Days 169-337
Triptorelin PK Metrics for Both Injections: Cmax
Time Frame: Days 1-169 and Days 169-337
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
Days 1-169 and Days 169-337

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Debiopharm International SA

Collaborators

Quintiles, Inc.

Investigators

  • Study Director: Eija Lundstrom, MD, Debiopharm SA
  • Principal Investigator: J. Bahlmann, MD, Private Practitioner

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Debio 8206-SC-301
  • KRA75538 (Other Identifier: Quintiles)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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