臨床研究等提出・公開システム

An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies (Darolutamide roll-over study)

Study to cotinue treatment with darolutamide in patients who have been participating in previous darolutamide studies supported by Bayer

Tanigawa Takahiko

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

byl_ct_contact@bayer.com

Dedicated contact

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

+81-6-6133-6363

byl_ct_contact@bayer.com

Not Recruiting

Jan. 15, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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 outlined in the feeder study protocol.
- Willingness to continue practicing acceptable methods of birth control during the study.

- 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.

Male

Cancer

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

Safety

Number of dose modifications

+81-42-778-9965

Nov. 11, 2020

No

USA/Argentina/Australia/ Belarus/ Belgium/Brazil/Bulgaria/Canada/Colombia/Czechia/Estonia/Finland/France/Germany/Hungary/ Italy/Korea/ Latvia/Lithuania/Peru/ Poland/Portugal/Romania/Russia/Slovakia/South Africa/ Spain/Sweden/Taiwan/Turkey