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, Inc.
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT01656161
First received: July 31, 2012
Last updated: August 13, 2015
Last verified: August 2015
  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 Phase
Prostate Cancer
Drug: Triptorelin embonate 22.5 mg
Phase 3

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:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337 [ Time Frame: Baseline through Day 337 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC) [ Time Frame: Days 1-169 ] [ Designated as safety issue: No ]
  • Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax) [ Time Frame: Days 1-169 ] [ Designated as safety issue: No ]
  • Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax) [ Time Frame: Days 1-169 ] [ Designated as safety issue: No ]
  • Testosterone PD Metrics for First Injection: Time to Castration (Tcast) [ Time Frame: Days 1-169 ] [ Designated as safety issue: No ]
  • Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC) [ Time Frame: Days 1-169 and Days 169-337 ] [ Designated as safety issue: No ]
  • Triptorelin PK Metrics for Both Injections: Cmax [ Time Frame: Days 1-169 and Days 169-337 ] [ Designated as safety issue: No ]
  • Triptorelin PK Metrics for Both Injections: Concentration 0 Hour [ Time Frame: Days 1-169 and Days 169-337 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   Child, Adult, Senior
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, Inc.
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
Results First Received: August 13, 2015
Last Updated: August 13, 2015
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 23, 2016