Study of Efficacy and Safety of Sunitinib Given on an Individualized Schedule
Status:
Completed
Trial end date:
2017-09-30
Target enrollment:
Participant gender:
Summary
This prospective single arm study will evaluate the efficacy and safety of sunitinib given on
an individualized dosing schedule as first-line therapy in subjects with metastatic clear
cell renal cell cancer. The treatment schedule intent is to maximize dose intensity of
sunitinib and minimize time off therapy based on individual tolerability using protocol
directed dose modification criteria. A total of 110 subjects will be enrolled. All subjects
will continue to receive study treatment until disease progression or withdrawal of consent.
The primary outcome for this study is progression-free survival (PFS), defined as the
duration from the date a patient first receives Sunitinib until the date of death or
confirmed progression according to the RECIST criteria.