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

Official record

Identifier

NCT03436485

Recruiting locations

countries

United StatesFinlandFranceUnited Kingdom

Interventions studied

ODM-208Midazolam

Lead sponsor

Orion Corporation, Orion Pharma

Target enrolment

204 participants

Study type

INTERVENTIONAL

Phase

Phase 1/2

Status

Active, not recruiting

First posted

Feb 19, 2018

Last updated on the registry

Aug 14, 2026

Age

18 Years

Sex

MALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Prostate Cancer