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A clinical study of regorafenib in participants who have been treated in previous Bayer-sponsored regorafenib studies that have been completed

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 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080224680
Enrollment
50
Registered
2019-05-14
Start date
2019-05-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

hepatocellular carcinoma

Interventions

investigational material(s) Generic name etc : Regorafenib INN of investigational material : regorafenib Therapeutic category code : --- Other Dosage and Administration for Investigational material :

Sponsors

Bayer Yakuhin, Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: - Participant must be age-eligible in the feeder study at the time of signing the informed consent. - Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving study treatment. - Participant is currently benefiting from treatment with regorafenib monotherapy and meets criteria to initiate a subsequent cycle of 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 not requiring further treatment interruption by the investigator.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: - Medical reasons not to start the next treatment cycle in the respective feeder - Pregnancy

Design outcomes

Primary

MeasureTime frame
safety Up to 57 months

Secondary

MeasureTime frame
other Up to 57 months

Countries

Asia except Japan, Europe, Japan, North America

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: Jul 3, 2026