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NCT06395753Not yet recruiting

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

A Phase 2, Randomized, Open-Label, Dose-Finding Study of Debio 4228, an Extended-Release Formulation of Gonadotropin-Releasing Hormone Antagonist in Participants With Locally Advanced/Metastatic Prostate Cancer
Debiopharm International SAPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Prostate Cancer
Drug/Device/Intervention
Debio 4228
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Debiopharm International SA
Timeline & enrollment
Phase
Phase 2
Start date
Jun 01, 2024
End date
Apr 01, 2026
Enrollment
60 participants
Primary outcome

Maximum Plasma Concentration (Cmax) of Debio 4228,Area Under the Concentration-time Curve of Debio 4228 Over 12 weeks (AUC84d),Plasma Concentration of Debio 4228 at Week 12 (C84d),Serum Concentration of Testosterone

Summary

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

ICD-10 classifications
Malignant neoplasm of prostateHyperplasia of prostateDisorder of prostate, unspecifiedOther disorders of prostateCarcinoma in situ: Prostate
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06395753
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06395753 through Pure Global AI's free database. This Phase 2 trial is sponsored by Debiopharm International SA and is currently Not yet recruiting. The study focuses on Prostate Cancer. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.