The trial is taking place at:
A

Associated Medical Professionals of NY, PLLC | Syracuse, NY

Veeva-enabled site

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

Bayer logo

Bayer

Status and phase

Enrolling
Phase 3

Conditions

Cancer

Treatments

Drug: Darolutamide (Nubeqa, BAY1841788)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04464226
2019-003618-15 (EudraCT Number)
20321

Details and patient eligibility

About

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.

Enrollment

678 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

678 participants in 1 patient group

Darolutamide (BAY1841788)
Experimental group
Description:
Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.
Treatment:
Drug: Darolutamide (Nubeqa, BAY1841788)

Trial contacts and locations

349

Loading...

Central trial contact

Bayer Clinical Trials Contact

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems