Prostatic Neoplasms
Conditions
Interventions
investigational material(s)
Generic name etc : BAY 1841788 / ODM-201
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
Bayer Yakuhin, Ltd.
Orion Pharma
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed adenocarcinoma of prostate. - Metastatic disease - Candidates for ADT and docetaxel. Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization - An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate bone marrow, liver and renal function
Exclusion criteria
Exclusion criteria: - Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, ODM-201; other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer, chemotherapy or immunotherapy for prostate cancer prior to randomization. - Treatment with radiotherapy - Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment. - Inability to swallow oral medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall survival Approximately 70 months From date of randomization until death from any cause, during treatment and during active and long term follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Time to castration resistant prostate cancer Time to initiation of subsequent antineoplastic therapy Symptomatic skeletal event free survival (SSE-FS) Time to first symptomatic skeletal event (SSE) Time to initiation of opioid use Time to pain progression Time to worsening of physical symptoms of disease Number of participants with adverse events as a measure of safety Approximately 70 months | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public Contactcontact Dedicated
Bayer Yakuhin, Ltd.
Outcome results
None listed