Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
Sponsor: Orion Corporation, Orion Pharma
ClinicalTrials ID:NCT03436485
This study assesses the safety and tolerability of ODM-208 in men with metastatic castration-resistant prostate cancer. Eligible participants must have confirmed adenocarcinoma, ongoing androgen deprivation therapy, and prior AR-targeted therapy. ODM-208 is administered orally with glucocorticoid and fludrocortisone, alongside midazolam. Participants must meet specific health criteria and have prior chemotherapy experience.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Description
Safety and tolerability profile of ODM-208 will be explored
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Maryland Marlene and Stewart Greenebaum Cancer Center | 21201 | Baltimore | Maryland |
| Masonic Cancer Center, University of Minnesota | 55455 | Minneapolis | Minnesota |
| Nebraska Cancer Specialists | 68114 | Omaha | Nebraska |
| University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative | 14203 | Buffalo | New York |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.