Phase II study of sunitinib rechallenge in patients with metastatic renal cell carcinoma.
Sunitinib rechallenge in patients with mRCC
In: Patients who progressed on first-line treatment with sunitinib and who had clinical benefit defined as a response (according to RECIST 1.1 criteria) or SD for more than 6 months on this treatment; Patients who progressed after second-line treatment (mTOR inhibitor or other treatment as long as patients are not treated with a VEGF targeted TKI, see exclusion criteria), or who progressed after a treatment-free interval of at least 3 months since discontinuation of first-line sunitinib treatment. Ex: Patients treated with any VEGF targeted TKI (sorafenib, pazopanib, axitinib, dovitinib) as second-line treatment after progression on first-line sunitinib treatment; Uncontrolled hypertension; macroscopic hematuria.
Prof. dr. H.M.W. Verheul