Metastatic castration-resistant prostate cancer.
Conditions
Brief summary
- Safety: adverse events, vital signs including blood pressure, heart rate, body temperature and orthostatic test (part 1 only), 12-lead ECGs; physical exams, laboratory assessments: hematology, chemistry, urinalysis. Determined at several time-points - MTD/DLTs - Efficacy assessments: Serum total PSA, soft tissue response by CT or MRI scan, bone scan, ECOG performance score. Circulating tumour cell (CTC) response (Part 2 only)
Detailed description
- Pharmacokinetic assessments: Multiple blood samples for PK; Plasma samples for protein binding - Metabolite screening: Multiple blood samples and urine collection - Recommended dose for further studies. - evaluate different AR LBD activating mutations and their association with antitumour activity of ODM-208., Exploratory: - Pharmacodynamic assessments: Testosterone level and other steroid hormones; - Biomarker assessments: Biomarkers in plasma may be performed on the steroid hormone samples; Germline DNA and pharmacogenomics. - to evaluate the relationship between AR-V7 splicing variant and antitumor activity of ODM-208 (Part 2/Phase 2 only), Exploratory: - molecular biomarkers at genomic, protein and metabolite level from plasma/serum - overall survival assessment (Part 2/Phase 2 only)
Interventions
DRUGMIDAZOLAM
DRUGODM-208 100 mg Tablet
DRUGODM-208 50 mg Tablet
DRUGODM-208 25 mg Tablet
DRUGODM-208 5 mg film-coated tablet
Sponsors
Orion Corporation
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety: adverse events, vital signs including blood pressure, heart rate, body temperature and orthostatic test (part 1 only), 12-lead ECGs; physical exams, laboratory assessments: hematology, chemistry, urinalysis. Determined at several time-points - MTD/DLTs - Efficacy assessments: Serum total PSA, soft tissue response by CT or MRI scan, bone scan, ECOG performance score. Circulating tumour cell (CTC) response (Part 2 only) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pharmacokinetic assessments: Multiple blood samples for PK; Plasma samples for protein binding - Metabolite screening: Multiple blood samples and urine collection - Recommended dose for further studies. - evaluate different AR LBD activating mutations and their association with antitumour activity of ODM-208., Exploratory: - Pharmacodynamic assessments: Testosterone level and other steroid hormones; - Biomarker assessments: Biomarkers in plasma may be performed on the steroid hormone samples; Germline DNA and pharmacogenomics. - to evaluate the relationship between AR-V7 splicing variant and antitumor activity of ODM-208 (Part 2/Phase 2 only), Exploratory: - molecular biomarkers at genomic, protein and metabolite level from plasma/serum - overall survival assessment (Part 2/Phase 2 only) | — |
Countries
Finland, France
Outcome results
None listed