Trial Condition(s):

Castration-Resistant Prostate Cancer

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)

Bayer Identifier:

18035

ClinicalTrials.gov Identifier:

NCT01429064

EudraCT Number:

2010-022803-24

Study Completed

Trial Purpose

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).

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
76
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Faculty Hospital Hradec Králové

Hradec Králové, Czech Republic, 500 05

Status
Completed
 
Locations

East Tallinn Central Hospital

Tallinn, Estonia, 10138

Status
Completed
 
Locations

Helsinki University Central Hospital

Helsinki, Finland, 00029

Status
Completed
 
Locations

Tampere University Hospital

Tampere, Finland, 33521

Status
Completed
 
Locations

Kuopio University Hospital

Kuopio, Finland, 70211

Status
Completed
 
Locations

Oulu University Hospital

Oulu, Finland, 90029

Status
Completed
 
Locations

Turku University Hospital

Turku, Finland, 20521

Status
Completed
 
Locations

Institut Gustave Roussy

Villejuif, France, 94805

Status
Completed
 
Locations

Hôpital Saint Louis

Paris, France, 75745

Status
Completed
 
Locations

Queen Elizabeth Hospital

Birmingham, United Kingdom, B15 2TH

Status
Completed
 
Locations

Cardiff University And Velindre Cancer Centre

Cardiff, United Kingdom, CF14 2TL

Status
Completed
 
Locations

Christie Hospital NHS Foundation Trust

Manchester, United Kingdom, M204BX

Status
Completed
 
Locations

Churchill Hospital

Oxford, United Kingdom, OX3 7LJ

Status
Completed
 
Locations

Cleveland Clinic

Cleveland, United States, 44195

Status
Completed
 
Locations

Urology Center Colorado

Urology, United States, 80211

Status
Completed
 
Locations

Carolina Urologic Research Center

Myrtle Beach, United States, 29572

Status
Completed
 
Locations

Eastern CT Hematology And Oncology

Norwich, United States, 06360

Status
Completed
 

Trial Design