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A Dose Finding Study of Debio 4228 in Participants With Locally Advanced/Metastatic Prostate Cancer - Trial NCT06395753

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.

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NCT06395753
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06395753
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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

Study Focus

Prostate Cancer

Debio 4228

Interventional

drug

Sponsor & Location

Debiopharm International SA

Timeline & Enrollment

Phase 2

Jun 01, 2024

Apr 01, 2026

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 prostate
Hyperplasia of prostate
Disorder of prostate, unspecified
Other disorders of prostate
Carcinoma in situ: Prostate

Data Source

ClinicalTrials.gov

NCT06395753

Non-Device Trial