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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656161
• Other study ID #: Debio 8206-SC-301
• Secondary ID: KRA75538
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2012
• Last updated: August 13, 2015
• Start date: July 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2015
• Source: Debiopharm International SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Triptorelin embonate 22.5 mg

Locations

Country	Name	City	State
South Africa	New Groote Schuur Hospital, Division of Urology	Cape Town
South Africa	JCM Bahlmann	George	Eastern Cape
South Africa	East Rand Urology Research Unit, Clinix Private Clinic	Johannesburg	Gautang
South Africa	Clinresco Centres (Pty) Ltd	Kempton Park	Gauteng
South Africa	Wilmed Park Hospital	Klerksdorp	North West Province
South Africa	Paarl Medical Centre	Paarl	Cape Town, Western Cape
South Africa	Clinical Trial Unit, Room 2-54, Prinshof Medical Campus	Pretoria	Gauteng
South Africa	Pretoria Urology Hospital	Pretoria	Gauteng
South Africa	Vergelegen Medi-Clinic	Somerset West	Cape Town
South Africa	Department of Urology, Tygerberg Hospital	Tygerberg	Cape Town

Sponsors (2)

Lead Sponsor	Collaborator
Debiopharm International SA	Quintiles, Inc.

Country where clinical trial is conducted

South Africa, 

References & Publications (2)

Klippel KF, Winkler CJ, Jocham D, Rübben H, Möser 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. German. — View Citation

Tornøe CW, Agersø 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. Epub 2006 Nov 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)		within 337 days	No
Secondary	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		on Days 1 and 169	No
Secondary	Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337		Baseline through Day 337	No
Secondary	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)		Day 171	No
Secondary	Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)		Days 1-169	No
Secondary	Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)		Days 1-169	No
Secondary	Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)		Days 1-169	No
Secondary	Testosterone PD Metrics for First Injection: Time to Castration (Tcast)		Days 1-169	No
Secondary	Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)		Days 1-169 and Days 169-337	No
Secondary	Triptorelin PK Metrics for Both Injections: Cmax		Days 1-169 and Days 169-337	No
Secondary	Triptorelin PK Metrics for Both Injections: Concentration 0 Hour		Days 1-169 and Days 169-337	No

External Links

•   Company website