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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03436485
Other study ID # 3124001
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 19, 2018
Est. completion date December 2024

Study information

Verified date January 2024
Source Orion Corporation, Orion Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Safety and tolerability profile of ODM-208 will be explored


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 204
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ODM-208
co-administered with glucocorticoid and fludrocortisone, orally daily
Midazolam
orally

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

United States,  Finland,  France,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) Highest dose level at which under 33% of patients in a cohort experience DLT Within first 28 days of treatment
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