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

Prostate Cancer Metastatic Clinical Trial

— CYPIDES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03436485
• Other study ID #: 3124001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Prostate Cancer Metastatic
• Prostatic Neoplasms

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