CompletedPhase 2

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

United States, Germany, Italy6 participantsStarted 2019-04-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

Timeframe: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

Timeframe: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)

Timeframe: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)

Timeframe: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

Trial details

NCT IDNCT03890731

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-28

Results submitted2024-02-07

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