Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (DUALIDES)

December 17, 2019 updated by: Orion Corporation, Orion Pharma

Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion

The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.

Study Type

Interventional

Enrollment (Actual)

23

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 Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital
  • France
      • Villejuif, France
        • Institut Gustave Roussy
  • Latvia
      • Riga, Latvia
        • P. Stradins Clinical University Hospital
  • United Kingdom
      • Cardiff, United Kingdom
        • Velindre Cancer Centre

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

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Written informed consent (IC) obtained.
  • Male aged ≥ 18 years.
  • Histologically or cytologically confirmed adenocarcinoma of prostate.
  • Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy.
  • Progressive metastatic disease
  • Adequate bone marrow, hepatic, and renal function
  • Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment
  • Ability to swallow study treatments

Exclusion Criteria:

  • History of pituitary or adrenal dysfunction.
  • Known brain metastases.
  • Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
  • Uncontrolled hypertension
  • Clinically significant heart disease
  • Prolonged QTc 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-204 Phase I dose escalation
Dose escalation
Drug: ODM-204
co-administered with prednisone, orally daily
Drug: Prednisone
ODM-204 is co-administered with oral prednisone
Experimental: ODM-204 Phase II dose expansion
Drug: ODM-204
co-administered with prednisone, orally daily
Drug: Prednisone
ODM-204 is co-administered with oral prednisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability assessed by incidence of adverse events
Time Frame: Until disease progression, an expected average of 6 months
Until disease progression, an expected average of 6 months
Safety and tolerability assessed by vitals signs and 12-lead ECG
Time Frame: Until disease progression, an expected average of 6 months
Until disease progression, an expected average of 6 months
Safety and tolerability assessed by laboratory assessments
Time Frame: Until disease progression, an expected average of 6 months
Until disease progression, an expected average of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic profile assessed by plasma peak concentration (Cmax)
Time Frame: 0 - week 12
0 - week 12
Pharmacokinetic profile assessed by area under the concentration-time curve (AUC)
Time Frame: 0 - week 12
0 - week 12
Pharmacokinetic profile assessed by time to reach peak concentration (tmax)
Time Frame: 0 - week 12
0 - week 12
Preliminary antitumour activity assessed by prostate specific antigen (PSA) response
Time Frame: Until disease progression, an expected average of 6 months
Until disease progression, an expected average of 6 months
Preliminary antitumour activity assessed by response in soft and bone tissues
Time Frame: Until disease progression, an expected average of 6 months
Until disease progression, an expected average of 6 months
Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements
Time Frame: 0 - week 12
0 - week 12

Collaborators and Investigators

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

Sponsor

Orion Corporation, Orion Pharma

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

February 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

December 29, 2014

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3116001

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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