NCT02058901

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Sunitinib

Timeline

• Start date: 2013-07-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2014-02-10
• Last updated: 2019-07-17

Locations

1 site across 1 country: Netherlands