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OpenTrials
Active, Not Recruiting

NCT Number: NCT04464226

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Urología, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Darolutamide (Nubeqa, BAY1841788)

Drug

Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.

Other names: ODM-201

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 4 years

  2. Incidence of treatment-emergent serious adverse events (TESAEs)

    Time frame: Up to 4 years

  3. Incidence of drug-related TEAEs

    Time frame: Up to 4 years

  4. Incidence of drug-related TESAEs

    Time frame: Up to 4 years

Secondary outcomes

  1. Number of dose modifications

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2020
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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