Last updated on August 2016

A Study of SKLB1028 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia


Brief description of study

Patients will receive oral SKLB1028 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.

Detailed Study Description

It is open-label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered SKLB1028 as a single agent given daily for 28 days. Cohorts of 3 patients receive SKLB1028 until dose limiting toxicity is noted (DLT). At that point cohorts will expand to 6 patients until MTD is determined. Patients not experiencing DLT or significant disease progression could continue receiving SKLB1028 up to 1 year.

Clinical Study Identifier: NCT02859948

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Ting Liu, Dr.

West China Hospital Sichuan University
Chengdu, China
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