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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: ODM-204; Drug: Prednisone

• Registration Number: NCT02344017
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-12-29
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-22
• Study Start: 2015-02
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ODM-204 Phase II dose expansion	ODM-204	-
ODM-204 Phase I dose escalation	ODM-204	Dose escalation
ODM-204 Phase I dose escalation	Prednisone	Dose escalation
ODM-204 Phase II dose expansion	Prednisone	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

P. Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Velindre Cancer Centre; 🇬🇧 Cardiff, United Kingdom