A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored… (NCT03890731) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)
3
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)
4
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)