Spots Global Cancer Trial Database for A Study of SKLB1028 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

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Trial Identification

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

Official Title: Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKLB1028 When Administered Daily to Patients With Relapsed or Refractory Acute Myeloid Leukemia

Study ID: NCT02859948

Conditions

Acute Myeloid Leukemia

Interventions

SKLB1028

Study Description

Brief Summary: 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 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.