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

NCT01656161 | Completed Phase 3 Results

• 2 other identifiers: Debio 8206-SC-301KRA75538
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 10

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

  within 337 days

Secondary Outcomes (10)

• 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

• Percentage Change From Baseline in Prostate Specific Antigen (PSA) 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)

  Day 171

• Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)

  Days 1-169

• Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)

  Days 1-169

Study Arms (1)

Triptorelin embonate 22.5 mg

EXPERIMENTAL

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

Interventions

Triptorelin embonate 22.5 mg DRUG

Also known as: Pamorelin

Triptorelin embonate 22.5 mg

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Debiopharm International SA: lead
• Quintiles, Inc.: collaborator

Study Sites (10)

Paarl Medical Centre

Paarl, Cape Town, Western Cape, 7646, South Africa

Location

Vergelegen Medi-Clinic

Somerset West, Cape Town, 7130, South Africa

Location

Department of Urology, Tygerberg Hospital

Tygerberg, Cape Town, 7505, South Africa

Location

JCM Bahlmann

George, Eastern Cape, 6530, South Africa

Location

East Rand Urology Research Unit, Clinix Private Clinic

Johannesburg, Gautang, 1475, South Africa

Location

Clinresco Centres (Pty) Ltd

Kempton Park, Gauteng, 1619, South Africa

Location

Clinical Trial Unit, Room 2-54, Prinshof Medical Campus

Pretoria, Gauteng, 0002, South Africa

Location

Pretoria Urology Hospital

Pretoria, Gauteng, 0028, South Africa

Location

Wilmed Park Hospital

Klerksdorp, North West, 2571, South Africa

Location

New Groote Schuur Hospital, Division of Urology

Cape Town, 7925, South Africa

Location

Related Publications (2)

• 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.

  PMID: 10407987 BACKGROUND

• 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.

  PMID: 17096678 BACKGROUND

Related Links

• Company website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Eija Lundstrom, Medical Director
• Organization: Debiopharm International

eija.lundstrom@debiopharm.com

+41 21 321 06 03

Study Officials

• Eija Lundstrom, MD

  Debiopharm SA

  STUDY DIRECTOR

• J. Bahlmann, MD

  Private Practitioner

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 2, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 15, 2015
• Results First Posted: September 15, 2015

Record last verified: 2015-08

Locations

ZA (10)