Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Description

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.

Conditions

Cancer

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Study Overview

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Study Details

Study 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.

An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Homewood

Urology Centers of Alabama, PC, Homewood, Alabama, United States, 35209

Chandler

Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr., Chandler, Arizona, United States, 85224

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

La Mesa

San Diego Clinical Trials, La Mesa, California, United States, 91942

Los Angeles

Tower Urology, Inc, Los Angeles, California, United States, 90048

Los Angeles

VA Greater Los Angeles Healthcare System, Los Angeles, California, United States, 90073-1003

Stanford

Stanford Health Care, Stanford, California, United States, 94305

Whittier

TOI Clinical Research, Whittier, California, United States, 90603

Aurora

VA Eastern Colorado Health Care System, Aurora, Colorado, United States, 80045

Denver

The Urology Center Of Colorado, Denver, Colorado, United States, 80211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bayer,

Study Record Dates

2028-06-26