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

Debiopharm

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Triptorelin embonate 22.5 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01656161

Debio 8206-SC-301

KRA75538 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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