Prostate Cancer
Conditions
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.
Interventions
DRUGODM-204
co-administered with prednisone, orally daily
DRUGPrednisone
ODM-204 is co-administered with oral prednisone
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements | 0 - week 12 |
| Preliminary antitumour activity assessed by response in soft and bone tissues | Until disease progression, an expected average of 6 months |
| 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 |
Countries
Finland, France, Latvia, United Kingdom
Outcome results
None listed