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

Study Identifier:
DEBIO-4228-201
CT.gov Identifier:
NCT06395753
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2024-511038-11-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

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

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Cohort 1
    • Read More
  • Drug: Experimental: Cohort 2
  • Drug: Experimental: Cohort 3
  • Drug: Intervention/treatment:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Inclusion Criteria:
    • Participant with histologically confirmed diagnosis of prostate cancer, with one of the following:
    • Newly diagnosed androgen-sensitive locally advanced or metastatic disease; or
    • Localized disease not suitable for local primary intervention with curative intent.
    • Participant judged by the Study Investigator to be candidate for continuous androgen deprivation therapy (ADT).
    • Baseline morning serum testosterone levels >150 ng/dL at screening visit.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
    • Life expectancy of at least 6 months.
    • Adequate bone marrow, hepatic, and renal function at the screening visit.
    • [Note: Other protocol and subprotocol-defined criteria apply]
    Exclusion criteria
    • Previous ADT (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and <6 months treatment-free interval before start of screening.
    • Participant requires combination with androgen deprivation therapy with the exception of enzalutamide.
    • History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
    • Received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer.
    • Abnormal cardiovascular function or diabetes.
    • Use of exogenous testosterone within 6 months before the start of screening.
    • Major surgery within 4 weeks before the start of screening.
    • Cancer disease within the last two years except for prostate cancer and some skin cancers.
    • [Note: Other protocol and subprotocol-defined criteria apply]

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruiting
    Condition(s) Treated at Site
    Prostate