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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: ODM-204
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ODM-204 Phase I dose escalation<br>Dose escalation | Drug: ODM-204<br>* co-administered with prednisone, orally daily<br>Drug: Prednisone<br>* ODM-204 is co-administered with oral prednisone<br>|
| Experimental: ODM-204 Phase II dose expansion<br> | Drug: ODM-204<br>* co-administered with prednisone, orally daily<br>Drug: Prednisone<br>* ODM-204 is co-administered with oral prednisone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |