Status:
ACTIVE_NOT_RECRUITING
Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Prostate Cancer Metastatic
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.
Detailed Description
Safety and tolerability profile of ODM-208 will be explored
Eligibility Criteria
Inclusion
- Main
- Written informed consent (IC) obtained.
- Male aged ≥ 18 years.
- Histologically confirmed adenocarcinoma of the prostate.
- Castration resistant prostate cancer with serum testosterone \< 50 ng/dl.
- Metastatic disease.
- Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
- Received at least one prior line of novel hormonal androgen receptor (AR) targeted therapy (e.g. abiraterone, enzalutamide).
- ECOG performance status 0-1.
- Adequate marrow, liver and kidney function.
- Able to swallow study treatment.
- Part 1: Treatment with at least 1 line of chemotherapy or ineligibility for chemotherapy. Part 2: Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC.
- Main
Exclusion
- History of pituitary or adrenal dysfunction.
- Known brain metastases or active leptomeningeal disease.
- Active infection or other medical condition that would make corticosteroid contraindicated.
- Poorly controlled diabetes.
- Hypotension or uncontrolled hypertension.
- Clinically significantly abnormal serum potassium or sodium level.
- Active or unstable cardio/cerebro-vascular disease including thromboembolic events.
- Prolonged QTcF interval.
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2026
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT03436485
Start Date
March 19 2018
End Date
July 31 2026
Last Update
July 22 2025
Active Locations (20)
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1
University of Maryland Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
2
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
3
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68114
4
University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative
Buffalo, New York, United States, 14203