A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
The primary objectives of the study are a) to allow patients from Bayer-sponsored trials to continue regorafenib treatment after their respective study has been completed, and b) to further assess the safety of regorafenib. Secondary objective is the documentation of drug tolerability.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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