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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT01656161
First received: July 31, 2012
Last updated: December 3, 2014
Last verified: December 2014
  Purpose

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.

Condition Intervention
Prostate Cancer
Drug: Triptorelin embonate 22.5 mg

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Debiopharm International SA:

Primary Outcome Measures:
  • Percentage of Participants achieving and maintaining castrate levels of serum testosterone (<1.735 nmol/L) [ Time Frame: within 337 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy [ Time Frame: Day 1 to Day 337 ] [ Designated as safety issue: Yes ]

    Secondary Efficacy

    1. Proportion of patients showing ≤ 1.0 IU/L increase in serum LH from 0 hour to 2 hours post-injection of first and second IMP injection.
    2. Percentage changes in PSA from baseline throughout treatment.
    3. Percentage of patients who show testosterone levels ≥ 1.735 nmol/L after the second injection (AOC).

    PK/PD (subset of 15 patients)

    1. Testosterone PD metrics in subset of 15 patients: AUC1-169d, Cmax, tmax, tcast.
    2. Triptorelin PK metrics in subset of 15 patients (for both injection periods): AUC1-169d, AUC169-337d, Cmax, tmax.


Enrollment: 120
Study Start Date: July 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Pamorelin

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01656161

Locations
South Africa
Paarl Medical Centre
Paarl, Cape Town, Western Cape, South Africa, 7646
Vergelegen Medi-Clinic
Somerset West, Cape Town, South Africa, 7130
Department of Urology, Tygerberg Hospital
Tygerberg, Cape Town, South Africa, 7505
JCM Bahlmann
George, Eastern Cape, South Africa, 6530
East Rand Urology Research Unit, Clinix Private Clinic
Johannesburg, Gautang, South Africa, 1475
Clinresco Centres (Pty) Ltd
Kempton Park, Gauteng, South Africa, 1619
Clinical Trial Unit, Room 2-54, Prinshof Medical Campus
Pretoria, Gauteng, South Africa, 0002
Pretoria Urology Hospital
Pretoria, Gauteng, South Africa, 0028
Wilmed Park Hospital
Klerksdorp, North West Province, South Africa, 2571
New Groote Schuur Hospital, Division of Urology
Cape Town, South Africa, 7925
Sponsors and Collaborators
Debiopharm International SA
Quintiles
Investigators
Study Director: Eija Lundstrom, MD Debiopharm SA
Principal Investigator: J. Bahlmann, MD Private Practitioner
  More Information

Additional Information:
Publications:
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01656161     History of Changes
Other Study ID Numbers: Debio 8206-SC-301, KRA75538
Study First Received: July 31, 2012
Last Updated: December 3, 2014
Health Authority: South Africa: Medicines Control Council

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 May 21, 2015