Phase 2
Completed N=6
A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed
Solid Cancer
Source: ClinicalTrials.gov NCT03890731 ↗
Enrolled (actual)
6
Serious AEs
50.0%
Results posted
Apr 2024
Primary outcomePrimary: Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs) — 6; 6; 3 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs) |
6; 6; 3 | — |
| PRIMARY Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs) |
0; 2; 1; 3; 0 | — |
| PRIMARY Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs) |
5; 5; 1 | — |
| PRIMARY Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs) |
1; 3; 0; 1; 0 | — |
| SECONDARY Number of Participants With Dose Modifications |
6; 2; 5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03890731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.