Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer
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.
|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|
- 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 efficacy [ Time Frame: Day 1 to Day 337 ] [ Designated as safety issue: Yes ]
- 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.
- Percentage changes in PSA from baseline throughout treatment.
- Percentage of patients who show testosterone levels ≥ 1.735 nmol/L after the second injection (AOC).
PK/PD (subset of 15 patients)
- Testosterone PD metrics in subset of 15 patients: AUC1-169d, Cmax, tmax, tcast.
- Triptorelin PK metrics in subset of 15 patients (for both injection periods): AUC1-169d, AUC169-337d, Cmax, tmax.
|Study Start Date:||July 2012|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656161
|Paarl Medical Centre|
|Paarl, Cape Town, Western Cape, South Africa, 7646|
|Somerset West, Cape Town, South Africa, 7130|
|Department of Urology, Tygerberg Hospital|
|Tygerberg, Cape Town, South Africa, 7505|
|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|
|Study Director:||Eija Lundstrom, MD||Debiopharm SA|
|Principal Investigator:||J. Bahlmann, MD||Private Practitioner|