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

NCT03436485

Active Not RecruitingPhase 1, Phase 2

Sponsor: Orion Corporation, Orion Pharma

Conditions: Prostate Cancer Metastatic

Interventions: ODM-208, Midazolam

Countries: United States, Finland, France, United Kingdom

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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (20)
  • Baltimore, Maryland, United States
  • Minneapolis, Minnesota, United States
  • Omaha, Nebraska, United States
  • Buffalo, New York, United States
  • Helsinki, Finland
  • Tampere, Finland
  • Bordeaux, France
  • Lyon, France
  • Marseille, France
  • Strasbourg, France
  • Suresnes, France
  • Villejuif, France
  • Bedlington, United Kingdom
  • Cardiff, United Kingdom
  • Glasgow, United Kingdom
  • Liverpool, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom
  • Preston, United Kingdom