Prostate Cancer Clinical Trial

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

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.

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Full Description

Safety and tolerability profile of ODM-208 will be explored

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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.
Part 2: Identified activating mutation in the LBD of AR in plasma ctDNA confirmed by the central testing.

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

192

Study ID:

NCT03436485

Recruitment Status:

Active, not recruiting

Sponsor:

Orion Corporation, Orion Pharma

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There are 8 Locations for this study

See Locations Near You

University of Maryland Marlene and Stewart Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68114, United States
University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative
Buffalo New York, 14203, United States
Helsinki University Central Hospital
Helsinki , , Finland
Tampere University Hospital
Tampere , , Finland
Institute Bergonié
Bordeaux , , France
Centre Léon Bérard
Lyon , , France
Institute Paoli-Calmettes
Marseille , , France
Institut de cancérologie Strasbourg Europe
Strasbourg , , France
Hopital Foch
Suresnes , 92150, France
Institut Gustave Roussy
Villejuif , , France
The Rutherford Cancer Centre, North East
Bedlington , , United Kingdom
Velindre Cancer Centre
Cardiff , CF14 , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
The Rutherford Cancer Centre, North West
Liverpool , , United Kingdom
Royal Marsden Hospital
London , SW3 6, United Kingdom
Charing Cross Hospital
London , , United Kingdom
The Christie NHS Foundation Trust
Manchester , , United Kingdom
Royal Preston Hospital
Preston , PR2 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

192

Study ID:

NCT03436485

Recruitment Status:

Active, not recruiting

Sponsor:


Orion Corporation, Orion Pharma

How clear is this clinincal trial information?

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