A Clinical Trial of Regorafenib in Patients With Pretreated Advanced Melanoma
Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
16 patients will receive a daily dose of 80mg regorafenib up until progressive disease,
unacceptable toxicity or withdrawal of consent. Dose can be escalated intra-patient up to 120
mg if no AE with a grad >1 at 28 days. Patients get a baseline evaluation and have a
consultation every 2 weeks for evaluation during treatment. This evaluation consists out of
lab tests, PET/CT (not bi-weekly), MRI (not bi-weekly) and physical evaluation.
Primary endpoint is the anti-tumor activity, secondary endpoints are the Overall Survival
Rate, Progression Free Survival and the incidence and severity of AE and Health-Related
Quality of Life.