Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
Phase 3 – large-scale trial before approval
Conditions:
Cancer
Sponsor: Bayer
trial.available_in:
БГ
Overview
The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.
Who can participate
Inclusion Criteria:
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
* Participants who have not met any treatment discontinuation criteria in the feeder study protocol.
* Willingness to continue practicing acceptable methods of birth control during the study.
Exclusion Criteria:
* Participant is unable to comply with the requirements of the study.
* Negative benefit/ risk ratio as determined by the investigator.
* Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.
Locations
36
Argentina (1)
Centro de Urología
Buenos Aires , Ciudad Auton. de Buenos Aires
Australia (1)
Adelaide Cancer Centre Research Pty Ltd
Kurralta Park , South Australia
Belarus (1)
N.N. Alexandrov National Cancer Centre of Belarus - Oncology Department
Lyasny , Minsk Oblast
Brazil (1)
Instituto do Cancer do Ceará
Fortaleza , Ceará
Bulgaria (1)
Medical Center Kalimat
Sofia , Sofia City Province
Canada (1)
Prostate Cancer Centre
Calgary , Alberta
China (1)
The Second Affiliated Hospital of Anhui Medical University
Hefei , Anhui
Colombia (1)
Hospital Pablo Tobón Uribe
Medellín , Antioquia
Czech Republic (1)
Masarykuv onkologicky ustav
Brno
Estonia (1)
Sihtasutus Põhja-Eesti Regionaalhaigla - Onkoloogia- ja hematoloogiakliinik
БГ