臨床研究等提出・公開システム

A single arm, open-label, multicenter Phase 2 study of regorafenib in participants who have been treated in a previous Bayer-sponsored regorafenib study (monotherapy or combination treatment) that has reached the primary completion endpoint or the main data analysis or has been stopped prematurely.

Regorafenib rollover study

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. 26, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving regorafenib as study treatment.
- Participant is currently benefiting from treatment with regorafenib monotherapy. All participants must meet criteria to initiate a subsequent cycleof therapy, as determined by the guidelines of the feeder protocol.
- Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and notrequiring further treatment interruption by the investigator.

- Ineligibility, for medical reasons, to start the subsequent cycle in the respective feeder study.
- Participants with a beta-human chorionic gonadotropin (hCG) test result consistent with pregnancy.
- Participants are using one or more of the prohibited medications listed in the respective feeder study protocol.
- Participant has been previously permanently discontinued from regorafenib treatment.

Both

Solid Tumors

Drug: Regorafenib (Stivarga, BAY73-4506)
Participants will be treated with the regorafenib dose taken during the last cycleof the feeder study. Adult participants will receive either 60, 80, 90, 120, or 160mg orally (p.o.) once daily (qd) for 3 weeks of every 4-week cycle (i.e. 3 weekson, 1 week off). Pediatric participants will receive 82 mg/m^2 p.o. qd for 14 days,in a 14 days on/7 days off schedule (21-day cycle).

Number of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity [ Time Frame: From the date theinformed consent form (ICF) was signed until the safety follow-up visit ]

Number of participants with dose modifications [ Time Frame: From the date the ICF was signed until the safety follow-up visit ]

+81-48-722-1111

Jan. 17, 2024

No

France/Korea/Spain/Taiwan