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

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ClinicalTrials.gov Identifier: NCT04464226
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Darolutamide (Nubeqa, BAY1841788) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : October 18, 2024
Estimated Study Completion Date : October 18, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Darolutamide (BAY1841788)
Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.
 Drug: Darolutamide (Nubeqa, BAY1841788)
Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.
Other Name: ODM-201


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of dose modifications [ Time Frame: Up to 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464226


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Sponsors and Collaborators
Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04464226    
Other Study ID Numbers: 20321
2019-003618-15 ( EudraCT Number )
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bayer:
Roll-Over Study