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

January 26, 2024 updated by: Orion Corporation, Orion Pharma
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Safety and tolerability profile of ODM-208 will be explored

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Orion Corporation, CSD

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital
      • Tampere, Finland
        • Tampere University Hospital
  • France
      • Bordeaux, France
        • Institute Bergonie
      • Lyon, France
        • Centre Leon Berard
      • Marseille, France
        • Institute Paoli-Calmettes
      • Strasbourg, France
        • Institut de cancerologie Strasbourg Europe
      • Suresnes, France, 92150
        • Hopital Foch
      • Villejuif, France
        • Institut Gustave Roussy
  • United Kingdom
      • Bedlington, United Kingdom
        • The Rutherford Cancer Centre, North East
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
      • Glasgow, United Kingdom, G12 0YN
        • The Beatson West of Scotland Cancer Centre
      • Liverpool, United Kingdom
        • The Rutherford Cancer Centre, North West
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • London, United Kingdom
        • Charing Cross Hospital
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Marlene and Stewart Greenebaum Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center, University of Minnesota
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Cancer Specialists
    • New York
      • Buffalo, New York, United States, 14203
        • University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ODM-208 Part 1 Dose escalation
Drug: ODM-208
co-administered with glucocorticoid and fludrocortisone, orally daily
Experimental: ODM-208 Part 2 Dose expansion
Drug: ODM-208
co-administered with glucocorticoid and fludrocortisone, orally daily
Experimental: ODM-208 Part 2 Drug drug interaction
Drug: ODM-208
co-administered with glucocorticoid and fludrocortisone, orally daily
Drug: Midazolam
orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD)
Time Frame: Within first 28 days of treatment
Highest dose level at which under 33% of patients in a cohort experience DLT
Within first 28 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Principal Investigator: Karim Fizazi, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3124001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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