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

  • End date
    Oct 18, 2024
  • participants needed
  • sponsor
Updated on 24 December 2020
Bayer Clinical Trials Contact
Primary Contact
Chesapeake Urology Associates (9.3 mi away) Contact
+225 other location


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.

Treatment Darolutamide (Nubeqa, BAY1841788)
Clinical Study IdentifierNCT04464226
Last Modified on24 December 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: malignant tumor or Neoplasms or Cancer or cancers or Ewing's Family Tumors or Cancer/Tumors or primary malignant neoplasm or malignancies or primary c...?
Do you have any of these conditions: malignancies or Cancer (Pediatric) or malignant tumors or primary cancer or Neoplasms or cancers or malignant tumor or malignancy or primary malignant...?
Do you have any of these conditions: malignant tumors or malignancy or primary cancer or cancers or malignancies or Ewing's Family Tumors or Cancer (Pediatric) or malignant tumor or Cance...?
Do you have any of these conditions: Cancer or primary cancer or malignant tumor or Neoplasms or cancers or malignancy or malignant tumors or Cancer (Pediatric) or Ewing's Family Tumors o...?
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
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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