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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Triptorelin embonate 22.5 mg
Sponsored by
Debiopharm International SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Paarl Medical Centre
  • Vergelegen Medi-Clinic
  • Department of Urology, Tygerberg Hospital
  • JCM Bahlmann
  • East Rand Urology Research Unit, Clinix Private Clinic
  • Clinresco Centres (Pty) Ltd
  • Clinical Trial Unit, Room 2-54, Prinshof Medical Campus
  • Pretoria Urology Hospital
  • Wilmed Park Hospital
  • New Groote Schuur Hospital, Division of Urology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triptorelin embonate 22.5 mg

Arm Description

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

Outcomes

Primary Outcome Measures

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

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
Percentage Change From Baseline in Prostate Specific Antigen (PSA) 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)
Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)
Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)
Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)
Testosterone PD Metrics for First Injection: Time to Castration (Tcast)
Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)
Triptorelin PK Metrics for Both Injections: Cmax
Triptorelin PK Metrics for Both Injections: Concentration 0 Hour

Full Information

First Posted
July 31, 2012
Last Updated
August 13, 2015
Sponsor
Debiopharm International SA
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01656161
Brief Title
Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Debiopharm International SA
Collaborators
Quintiles, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triptorelin embonate 22.5 mg
Arm Type
Experimental
Arm Description
Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
Intervention Type
Drug
Intervention Name(s)
Triptorelin embonate 22.5 mg
Other Intervention Name(s)
Pamorelin
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
Time Frame
within 337 days
Secondary Outcome Measure Information:
Title
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
Title
Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
Time Frame
Baseline through Day 337
Title
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
Title
Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)
Time Frame
Days 1-169
Title
Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)
Time Frame
Days 1-169
Title
Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)
Time Frame
Days 1-169
Title
Testosterone PD Metrics for First Injection: Time to Castration (Tcast)
Time Frame
Days 1-169
Title
Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)
Time Frame
Days 1-169 and Days 169-337
Title
Triptorelin PK Metrics for Both Injections: Cmax
Time Frame
Days 1-169 and Days 169-337
Title
Triptorelin PK Metrics for Both Injections: Concentration 0 Hour
Time Frame
Days 1-169 and Days 169-337

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eija Lundstrom, MD
Organizational Affiliation
Debiopharm SA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
J. Bahlmann, MD
Organizational Affiliation
Private Practitioner
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paarl Medical Centre
City
Paarl
State/Province
Cape Town, Western Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Vergelegen Medi-Clinic
City
Somerset West
State/Province
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Department of Urology, Tygerberg Hospital
City
Tygerberg
State/Province
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
JCM Bahlmann
City
George
State/Province
Eastern Cape
ZIP/Postal Code
6530
Country
South Africa
Facility Name
East Rand Urology Research Unit, Clinix Private Clinic
City
Johannesburg
State/Province
Gautang
ZIP/Postal Code
1475
Country
South Africa
Facility Name
Clinresco Centres (Pty) Ltd
City
Kempton Park
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Clinical Trial Unit, Room 2-54, Prinshof Medical Campus
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Pretoria Urology Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0028
Country
South Africa
Facility Name
Wilmed Park Hospital
City
Klerksdorp
State/Province
North West Province
ZIP/Postal Code
2571
Country
South Africa
Facility Name
New Groote Schuur Hospital, Division of Urology
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
10407987
Citation
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.
Results Reference
background
PubMed Identifier
17096678
Citation
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.
Results Reference
background
Links:
URL
http://www.debiopharm.com
Description
Company website

Learn more about this trial

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

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