Metastatic extramammary Paget's disease
Conditions
Sponsors
Nakamura Yoshio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed extramammary Paget's disease 2) Metastatic disease for which curative surgery or radiotherapy is not indicated 3) Patients must be at least 18 years old at the date of consent 4) One or more measurable diseases as defined in the RECIST Guidelines Version 1.1 on clinical and imaging findings within 14 days prior to enrollment 5) Female patients of childbearing potential who have agreed to use double contraception for at least 28 days after the last dose of the drugs used in this study from the time of consent and agreed not to breastfeed for at least 28 days after the last dose of the drugs used in this study from the date of consent 6) Male patients who have agreed to use double contraception for at least 90 days after the last dose of the drugs used in this study from the date of consent 7) Patients who have given written consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) Patients who have received the following prior therapies - Androgen receptor inhibitors - CYP 17 enzyme inhibitors - Luteinizing hormone-releasing hormone preparations 2) Patients with active infections requiring systemic therapy 3) Patients with poorly controlled diabetes mellitus 4) Patients with poorly controlled chronic liver disease 5) Patients with known hypersensitivity to the investigational drug or its components 6) Patients with poorly controlled hypertension 7) Patients with gastrointestinal disorders that are expected to significantly impair absorption of darolutamide or patients who have difficulty taking darolutamide 8) Patients with active viral hepatitis, or active human immunodeficiency virus infection 9) Patients with moderate or severe ascites or pleural effusion 10) Metastasis to the central nervous system 11) Uncontrolled tumor-related pain. 12) Avtive double cancer 13) Pregnant, lactating or patients with a positive pregnancy test 14) Patients participating in clinical trials using any other investigational drugs or medical devices within 30 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate by central review | — |
Secondary
| Measure | Time frame |
|---|---|
| - Response rate by site - Disease control rate - Change rate of target lesion - Maximum change rate of target lesion - Progression-free survival - Overall survival - Duration of response - Time to response - Adverse events | — |
Contacts
Public ContactHiroshi Miyamoto
FIVERINGS CO.,LTD.
Outcome results
None listed