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NCT03436485 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Prostate Cancer Metastatic, sponsored by Orion Corporation, Orion Pharma.

Active
Registry status
Phase 1
Development phase
204
Enrollment target
20
Study locations

NCT03436485 is a Phase 1 study of Prostate Cancer Metastatic that is active but no longer recruiting, run by Orion Corporation, Orion Pharma. The registered enrollment target is 204 participants, roughly in line with the 216-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target. The trial reports 20 study locations across 5 states.

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The verdict

NCT03436485, a Phase 1 study of Prostate Cancer Metastatic, is active but no longer recruiting, sponsored by Orion Corporation, Orion Pharma.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
204 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Prostate Cancer Metastatic

Interventions

  • DRUG Midazolam
  • DRUG ODM-208

Study Locations (20)

Other

  • Helsinki University Central Hospital - Helsinki
  • Tampere University Hospital - Tampere
  • Institute Bergonié - Bordeaux
  • Centre Léon Bérard - Lyon
  • Institute Paoli-Calmettes - Marseille
  • Institut de cancérologie Strasbourg Europe - Strasbourg
  • Hopital Foch - Suresnes
  • Institut Gustave Roussy - Villejuif
  • The Rutherford Cancer Centre, North East - Bedlington
  • Velindre Cancer Centre - Cardiff
  • The Beatson West of Scotland Cancer Centre - Glasgow
  • The Rutherford Cancer Centre, North West - Liverpool
  • Royal Marsden Hospital - London
  • Charing Cross Hospital - London
  • The Christie NHS Foundation Trust - Manchester
  • Royal Preston Hospital - Preston

Maryland

  • University of Maryland Marlene and Stewart Greenebaum Cancer Center - Baltimore

Minnesota

  • Masonic Cancer Center, University of Minnesota - Minneapolis

Nebraska

  • Nebraska Cancer Specialists - Omaha

New York

  • University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative - Buffalo

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2018-03-19
Est. Completion 2026-07-31
Phase Phase 1

Sponsor

Orion Corporation, Orion Pharma

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03436485

The ClinicalTrials.gov registry entry for NCT03436485 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 216-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target. The listed sponsor is Orion Corporation, Orion Pharma, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer Metastatic appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.

NCT03436485 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Other, Maryland, Minnesota.

Frequently Asked Questions

What is clinical trial NCT03436485 about?

NCT03436485 is a clinical study titled "Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer". 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.

What is the current status of trial NCT03436485?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 204 participants. The study started on 2018-03-19. Estimated completion is 2026-07-31.

What conditions does trial NCT03436485 study?

This clinical trial studies the following conditions: Prostate Cancer Metastatic.

What interventions are being tested in trial NCT03436485?

The interventions under investigation include: Midazolam (DRUG), ODM-208 (DRUG).

Who is sponsoring clinical trial NCT03436485?

This trial is sponsored by Orion Corporation, Orion Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03436485 being conducted?

This trial has 20 study locations across Maryland, Minnesota, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.