Study of Efficacy and Safety of Sunitinib Given on an Individualized Schedule

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.

Timeline

Start

2012-05

Primary completion

2017-09-30

Completion

2017-09-30

Outcome

Met primary endpoint

paper The null hypothesis was rejected (p < 0.001) with a median PFS of 12.5 months PMID 30648632 ↗

Publications

• Bjarnason GA, Knox JJ, Kollmannsberger CK, Soulieres D, Ernst DS, Zalewski P, Canil CM, Winquist E, Hotte SJ, North SA, Heng DYC, Macfarlane RJ, Venner PM, Kapoor A, Hansen AR, Eigl BJ, Czaykowski P, Boyd B, Wang L, Basappa NS. The efficacy and safety of sunitinib given on an individualised schedule as first-line therapy for metastatic renal cell carcinoma: A phase 2 clinical trial. Eur J Cancer. 2019 Feb;108:69-77. doi: 10.1016/j.ejca.2018.12.006. Epub 2019 Jan 14.

Drugs

Indications