Phase I Study of Safety and Pharmacokinetics of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors
This will be an open-label, phase I study. This study will evaluate the safety and
pharmacokinetics of HMPL-013 after a single administration followed by a 28-Day continuous
course of therapy; evaluate the safety and preliminary efficacy in an open-label
administration of at the MTD. All subjects of this study will be permitted to continue
therapy with only safety monitoring and bimonthly assessments for progression, if the
product is well tolerated and the subject has stable disease or better.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety in the first 28-Days of Therapy
The primary endpoint is evaluation of safety during the first 28-day cycle of therapy following the initiation of multiple dosing of HMPL-013. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate.
28-Days after Permanent Discontinuation of HMPL-013
China: Food and Drug Administration