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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 : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE July 7, 2020
First Posted Date  ICMJE July 9, 2020
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE October 20, 2020
Estimated Primary Completion Date October 18, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
Number of dose modifications [ Time Frame: Up to 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
Official Title  ICMJE An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Darolutamide (BAY1841788)
Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.
Intervention: Drug: Darolutamide (Nubeqa, BAY1841788)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2020)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 18, 2024
Estimated Primary Completion Date October 18, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   Czechia,   Estonia,   Finland,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04464226
Other Study ID Numbers  ICMJE 20321
2019-003618-15 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bayer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP