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Clinical Trials List

Protocol Number20321
NCT Number(ClinicalTrials.gov Identfier)NCT04464226

2020-10-16 - 2025-06-27

Others

Not yet recruiting4

Recruiting2

ICD-10C61

Malignant neoplasm of prostate

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9185

Malignant neoplasm of prostate

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

  • Trial Applicant

    BAYER TAIWAN COMPANY LTD.

  • Sponsor

    Bayer

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Shu-Pin Huang 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Kuang Yang 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator See-Tong Pang 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator CHUNG-HSIN CHEN 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiu Huang 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hsi-Chin Wu 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

non-metastatic castrate-resistant prostate cancer (nmCRPC)

Objectives

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.

Test Drug

BAY 1841788

Active Ingredient

darolutamide

Dosage Form

film-coated tablet

Dosage

300

Endpoints

Primary Outcome Measures :
Incidence of Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 4 years ]
Incidence of Treatment-emergent serious adverse events (TESAEs) [ Time Frame: Up to 4 years ]
Incidence of drug-related TEAEs [ Time Frame: Up to 4 years ]
Incidence of drug-related TESAEs [ Time Frame: Up to 4 years ]

Inclution Criteria

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

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.

The Estimated Number of Participants

  • Taiwan

    4 participants

  • Global

    520 participants

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