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ACTIVE NOT RECRUITING
NCT06395753
PHASE2

A Dose Finding Study of Debio 4228 in Participants With Advanced Prostate Cancer

Sponsor: Debiopharm International SA

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.

Official title: A Phase 2, Randomized, Open-Label, Dose-Finding Study of Debio 4228, an Extended-Release Formulation of Gonadotropin-Releasing Hormone Antagonist in Participants With Advanced Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2024-05-23

Completion Date

2027-01

Last Updated

2026-03-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Debio 4228

Administered as IM injection.

Locations (33)

Urologic Surgeons of Arizona

Mesa, Arizona, United States

East Valley Urology Center of Arizona

Queen Creek, Arizona, United States

Bakersfield Institute of Advanced Urology

Bakersfield, California, United States

Grimaldi Urology

Chula Vista, California, United States

Valley Urology

Fresno, California, United States

Urology Group of Southern California

Los Angeles, California, United States

Tower Urology,

Los Angeles, California, United States

Alarcon Urology Center

Montebello, California, United States

Urology Center of Southern California

Murrieta, California, United States

Pasadena Urological Medical Group

Pasadena, California, United States

AP Medical Research

Miami, Florida, United States

Biogenix Molecular

Miami, Florida, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

New York Cancer and Blood Specialists

Shirley, New York, United States

Associated Urologists of North Carolina

Raleigh, North Carolina, United States

Oregon Urology Institut

Springfield, Oregon, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Urology Clinics of North Texas

Dallas, Texas, United States

Urology of Virginia

Virginia Beach, Virginia, United States

Summit Cancer Centers of North Spokane

Spokane, Washington, United States

University Hospital Gent

Ghent, Belgium

AZ Groeninge

Kortrijk, Belgium

CHU Angers

Angers, France

CHRU de Brest - Hopital Morvan

Brest, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Georges Francois Leclerc

Dijon, France

CHU de Nantes - Hôtel Dieu

Nantes, France

AP-HP Hopital Pitie-Salpetriere

Paris, France

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Clinico San Carlos

Madroñera, Spain

Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

Sabadell, Spain

Instituto Valenciano de Oncologia

Valencia, Spain