Regorafenib rollover study
- Conditions
- Solid Tumors
- Registration Number
- JPRN-jRCT2031230602
- Lead Sponsor
- Tanigawa Takahiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1
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 cycleof 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 notrequiring further treatment interruption by the investigator.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity [ Time Frame: From the date theinformed consent form (ICF) was signed until the safety follow-up visit ]
- Secondary Outcome Measures
Name Time Method umber of participants with dose modifications [ Time Frame: From the date the ICF was signed until the safety follow-up visit ]