Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

Study Overview
=================
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

Official Title
-----------------
Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

Conditions
-----------------
Prostate Cancer Metastatic

Intervention / Treatment
-----------------
* Drug: ODM-208
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Main 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ODM-208 Part 1 Dose escalation<br> | Drug: ODM-208<br>* co-administered with glucocorticoid and fludrocortisone, orally daily<br>|
| Experimental: ODM-208 Part 2 Dose expansion<br> | Drug: ODM-208<br>* co-administered with glucocorticoid and fludrocortisone, orally daily<br>|
| Experimental: ODM-208 Part 2 Drug drug interaction<br> | Drug: ODM-208<br>* co-administered with glucocorticoid and fludrocortisone, orally daily<br>Drug: Midazolam<br>* orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) | Highest dose level at which under 33% of patients in a cohort experience DLT | Within first 28 days of treatment |