Trial Condition(s):
Study to learn more about the long-term safety of ODM-201 (Nubeqa, Darolutamide, BAY1841788) and how well the study drug acts in the human body of patients suffering from prostate cancer (ARADES-EXT)
18035
Not Available
The purpose of the study is to learn more about the long-term safety of ODM-201 (Nubeqa, Darolutamide, BAY1841788) in patients with prostate cancer that keeps growing and has spread to other parts of the body. In addition researchers want to gather information how well patients suffering from this type of prostate cancer respond to treatment with ODM-201. The study medication ODM-201 is an androgen receptor inhibitor tested in men with metastatic castration-resistant prostate cancer (mCRPC).
- Male patients aged 18 years or older with histologically confirmed adenocarcinoma of the prostate - Patients who successfully completed 12 weeks of treatment according to study protocol 3104001 (NCT01317641; Bayer 17829) without any serious drug-related adverse events or dose-limiting toxicities - Patient was expected to benefit from participation in the study in the opinion of the investigator - Patients with any response or stable disease in Study 3104001 at week 12
- Patients who received prior therapy with MDV3100 or any investigational androgen receptor antagonist - Patients who received chemotherapy, radiotherapy or any experimental therapy within 4 weeks (within 6 weeks for nitrosoureas and mitomycin C) of the start of study treatment or had not recovered to Grade ≤1 or returned to baseline from any acute treatment-related toxicities of the previous therapy except for alopecia and Grade 2 neuropathy - Therapy with oral ketoconazole or CYP17 inhibitor within 30 days prior to the start of study treatment
Locations | Status | |
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Locations Faculty Hospital Hradec Králové Hradec Králové, Czech Republic, 500 05 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations East Tallinn Central Hospital Tallinn, Estonia, 10138 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Helsinki University Central Hospital Helsinki, Finland, 00029 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tampere University Hospital Tampere, Finland, 33521 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kuopio University Hospital Kuopio, Finland, 70211 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Oulu University Hospital Oulu, Finland, 90029 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Turku University Hospital Turku, Finland, 20521 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Institut Gustave Roussy Villejuif, France, 94805 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital Saint Louis Paris, France, 75745 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Queen Elizabeth Hospital Birmingham, United Kingdom, B15 2TH | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cardiff University And Velindre Cancer Centre Cardiff, United Kingdom, CF14 2TL | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Christie Hospital NHS Foundation Trust Manchester, United Kingdom, M204BX | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Churchill Hospital Oxford, United Kingdom, OX3 7LJ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cleveland Clinic Cleveland, United States, 44195 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Urology Center Colorado Urology, United States, 80211 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Carolina Urologic Research Center Myrtle Beach, United States, 29572 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Eastern CT Hematology And Oncology Norwich, United States, 06360 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Safety and tolerability of ODM-201 in patients with castrate-resistant prostate cancer: Open, non-randomised, uncontrolled, multicenter, extension study to Study 3104001
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
6