Overview

A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed

Status:
Enrolling by invitation
Trial end date:
2023-11-09
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. Patients participating in this study will be observed to collect information on how safe the drugs are and how this treatment is tolerated.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
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:

- Medical reasons not to start the next treatment cycle in the respective feeder

- Pregnancy