Prostate Cancer
Conditions
Brief summary
The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.
Interventions
DRUGODM-201
ODM-201 administered orally daily
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Successful completion of study protocol 3104001 * Response or stable disease in study 3104001 at week 12
Exclusion criteria
* New serious concurrent medical condition * Not able to swallow the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | From first dose of study treatment up to 4 weeks after last dose of study treatment | Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months. |
Countries
Czechia, Estonia, Finland, France, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 17 hospitals in Europe and in the USA
Pre-assignment details
Patients with response or stable disease at week 12 in ARADES 3104001 study as judged by the investigator, were allowed to continue in the ARADES-EXT 3104002 extension study.
Participants by arm
| Arm | Count |
|---|---|
| Patients From Arades 3104001 Dose Escalation 200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day | 19 |
| Patients From Arades 3104001 Dose Expansion (200mg/Day) Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | 22 |
| Patients From Arades 3104001 Dose Expansion (400mg/Day) Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | 19 |
| Patients From Arades 3104001 Dose Expansion (1400mg/Day) Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | 16 |
| Total | 76 |
Baseline characteristics
| Characteristic | Patients From Arades 3104001 Dose Escalation | Patients From Arades 3104001 Dose Expansion (200mg/Day) | Patients From Arades 3104001 Dose Expansion (400mg/Day) | Patients From Arades 3104001 Dose Expansion (1400mg/Day) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 68.8 years STANDARD_DEVIATION 6.1 | 66.5 years STANDARD_DEVIATION 6.6 | 68.9 years STANDARD_DEVIATION 8.3 | 74.6 years STANDARD_DEVIATION 6.3 | 69.4 years STANDARD_DEVIATION 7.3 |
| Gender Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Gender Male | 19 Participants | 22 Participants | 19 Participants | 16 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 19 | 22 / 22 | 19 / 19 | 16 / 16 |
| serious Total, serious adverse events | 5 / 19 | 7 / 22 | 3 / 19 | 4 / 16 |
Outcome results
Primary
Number of Participants With Adverse Events
Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.
Time frame: From first dose of study treatment up to 4 weeks after last dose of study treatment
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients From Arades 3104001 Dose Escalation | Number of Participants With Adverse Events | 19 participants |
| Patients From Arades 3104001 Dose Expansion (200mg/Day) | Number of Participants With Adverse Events | 22 participants |
| Patients From Arades 3104001 Dose Expansion (400mg/Day) | Number of Participants With Adverse Events | 19 participants |
| Patients From Arades 3104001 Dose Expansion (1400mg/Day) | Number of Participants With Adverse Events | 16 participants |