A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies
NCT ID: NCT06246643
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
13 participants
INTERVENTIONAL
2024-01-24
2028-04-27
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Regorafenib
Adult and pediatric patients from completed Bayer-sponsored regorafenib trials who are benefiting from regorafenib treatment.
Regorafenib (Stivarga, BAY73-4506)
Participants will be treated with the regorafenib dose taken during the last cycle of the feeder study. Adult participants will receive either 60, 80, 90, 120, or 160 mg orally (p.o.) once daily (qd) for 3 weeks of every 4-week cycle (i.e. 3 weeks on, 1 week off). Pediatric participants will receive 82 mg/m\^2 p.o. qd for 14 days, in a 14 days on/7 days off schedule (21-day cycle).
Interventions
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Regorafenib (Stivarga, BAY73-4506)
Participants will be treated with the regorafenib dose taken during the last cycle of the feeder study. Adult participants will receive either 60, 80, 90, 120, or 160 mg orally (p.o.) once daily (qd) for 3 weeks of every 4-week cycle (i.e. 3 weeks on, 1 week off). Pediatric participants will receive 82 mg/m\^2 p.o. qd for 14 days, in a 14 days on/7 days off schedule (21-day cycle).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Hôpital Beaujon - Clichy
Clichy, , France
Hopital Claude Huriez - Lille
Lille, , France
Hôpital Paul Brousse - Villejuif
Villejuif, , France
Saitama Cancer Center
Kitaadachi-gun, Saitama, Japan
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Infantil Universitario Nino Jesus | Oncologia Pediatrica
Madrid, , Spain
China Medical University Hospital
Taichung, , Taiwan
Countries
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Related Links
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Other Identifiers
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2023-507084-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
22551
Identifier Type: -
Identifier Source: org_study_id