Spots Global Cancer Trial Database for Study of High-dose, Intermittent Sunitinib in Patients With Solid Tumors.

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Trial Identification

Brief Title: Study of High-dose, Intermittent Sunitinib in Patients With Solid Tumors.

Official Title: A Phase I Study of High-dose, Intermittent Sunitinib in Patients With Solid Tumors.

Study ID: NCT02058901

Conditions

Solid Tumors

Interventions

Sunitinib

Study Description

Brief Summary: The primary objective of this study is: * To determine the maximum tolerated dose (MTD) of sunitinib when administered once weekly or once every two weeks. * To assess the safety and tolerability of sunitinib in a once weekly or once every two weeks dose schedule.

Detailed Description: Our hypothesis is that sunitinib, when given in a high-dose, intermittent schedule may exhibit improved efficacy with an acceptable toxicity profile. In the present phase I trial, we aim to determine the maximum tolerated dose of sunitinib when administered high-dose, once weekly or once every two weeks. Furthermore, by acquiring skin and tumor biopsies, we will assess intratumoral concentrations of sunitinib, correlate these to skin and plasma concentrations and gain more insight into the biological effects of the drug. Additionally, we aim to preliminary assess the efficacy of sunitinib administered at the MTD level in both schedules. Known serum angiogenesis markers will be correlated to efficacy endpoints.