Regorafenib rollover study

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230602

Enrollment

Registered

2024-01-26

Start date

2024-03-15

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Interventions

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,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
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 ]	—

Secondary

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

Countries

France, Japan, Korea, Spain, Taiwan

Contacts

Public Contactcontact Dedicated

Bayer Yakuhin, Ltd.

byl_ct_contact@bayer.com+81-6-6133-6363

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 22, 2026