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

Launched by BAYER · Mar 25, 2019

Keywords

ClinConnect Summary

The primary objectives of the study are a) to allow patients from Bayer-sponsored trials to continue regorafenib treatment after their respective study has been completed, and b) to further assess the safety of regorafenib. Secondary objective is the documentation of drug tolerability.

Gender

ALL

Eligibility 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