drugset / Trial / NCT01286896

Use of Individual Pharmacokinetically (PK)-Guided Sunitinib Dosing: A Feasibility Study in Patients With Advanced Solid Tumors

NCT01286896

Phase 1 Completed 43 enrolled The Netherlands Cancer Institute Pfizer · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this prospective study is to determine the safety and feasibility of pharmacokinetically (PK) guided dosing of sunitinib in 30 patients. At day 15 ± 1day, day 29 ± 1day and after 8 weeks ± 1day of sunitinib treatment sunitinib and SU12662 trough levels will be measured. Depending on the sunitinib and SU12662 trough levels (and toxicity) dose adjustments will be made.

Timeline

Start
2011-04-11
Primary completion
2011-12-27
Completion
2011-12-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Sunitinib Small molecule 37.5 mg Oral

Indications