Active — Not RecruitingPhase 2

A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies

France, Japan, South Korea13 participantsStarted 2024-01-24

Plain-language summary

Regorafenib is an anti-cancer drug that blocks several proteins which are involved in the growth of cancer. It has been approved for different types of cancers of the digestive system and is being tested for use in some other solid tumors. Cancers that start in an organ, a muscle, or a bone form a solid tumor. This study is for participants with solid tumors who have been taking regorafenib in other Bayer studies. They can continue taking regorafenib if it is working when treatment with regorafenib in their previous study ends. The main purpose of this study is to find: * How safe is the continued treatment with regorafenib in participants with solid tumors? * How well is the continued treatment with regorafenib tolerated by participants with solid tumors? Participants will continue with the same dose of regorafenib that they were taking in their previous study as long as the treatment works for them/they want to continue the treatment/other medical conditions do not prevent them from participating in the study. For participants that are under 18 years of age, regorafenib tablets will be taken by mouth once daily for 2 weeks and repeat again after a 1-week gap. For participants that are over 18 years of age, regorafenib tablets will be taken by mouth once daily for 3 weeks and repeat again after a 1-week gap. At the start of the study, researchers will review participants' records from the previous study. During the study, researchers will use blood samples and X-rays taken from participants under the age of 18 years to check how safe regorafenib is for children. They will also monitor any medical problems that participants may have during the study. After the last dose, follow-up will be done either within 14 days when participants visit their study doctor or within 30-35 days by phone call. Both the researchers and the participants will know the dose of regorafenib the participants receive during the study.

Who can participate

Age range

10 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 is currently participating in any Bayer-sponsored regorafenib study and is receiving regorafenib as study treatment. * Participant is currently benefiting from treatment with regorafenib monotherapy. All participants must meet 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: * Ineligibility, for medical reasons, to start the subsequent cycle in the respective feeder study. * Participants with a beta-human chorionic gonadotropin (hCG) test result consistent with pregnancy. * Participants are using one or more of the prohibited medications listed in the respective feeder study protocol. * Participant has been previously permanently discontinued from regorafenib treatment.

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

Number of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity

Timeframe: through study completion, an average of 2.5 year

Trial details

NCT IDNCT06246643

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-27

View on ClinicalTrials.gov More Solid Malignant Tumors trials