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ACTIVE NOT RECRUITING Phase 1

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

NCT03436485 · View on ClinicalTrials.gov ↗

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

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

2 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orion Corporation, Orion Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03436485 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Maryland, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03436485?

The interventions under investigation include: Midazolam (DRUG), ODM-208 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03436485?

This trial is sponsored by Orion Corporation, Orion Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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