Status:
ACTIVE_NOT_RECRUITING
A Dose Finding Study of Debio 4228 in Participants With Advanced Prostate Cancer
Lead Sponsor:
Debiopharm International SA
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.
Eligibility 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]
Key Trial Info
Start Date :
May 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06395753
Start Date
May 23 2024
End Date
January 1 2027
Last Update
March 30 2026
Active Locations (33)
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1
Urologic Surgeons of Arizona
Mesa, Arizona, United States, 85206
2
East Valley Urology Center of Arizona
Queen Creek, Arizona, United States, 85140
3
Bakersfield Institute of Advanced Urology
Bakersfield, California, United States, 93301
4
Grimaldi Urology
Chula Vista, California, United States, 91910