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

  • STATUS
    Recruiting
  • End date
    Oct 18, 2024
  • participants needed
    500
  • sponsor
    Bayer
Updated on 24 December 2020
Investigator
Bayer Clinical Trials Contact
Primary Contact
Chesapeake Urology Associates (9.3 mi away) Contact
+225 other location

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.

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

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

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

Learn more
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.

Learn more
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.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet