NCT04015024

A Clinical Study of SKLB1028 Capsule in the Treatment of Recurrence/Refractory AML Patients

Phase IIa Clinical Study of SKLB1028 Capsule in the Treatment of FLT3 Mutation Recurrence / Refractory AML Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients will receive oral SKLB1028 for 28 days as a course of treatment, and then to evaluate the side effects,tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.

Detailed description

It is an open,multicenter,queue extension study designed to characterize the efficacy and safety of different administration regimens of SKLB1028 capsules in patients with recurrent/refractory acute myeloid leukemia with FLT3 mutation. Divided into three dose groups,150mg BID,200mg BID,300mg QD. The main end point is total remission rate (ORR), total survival time (OS), progress-free survival time (PFS), remission duration, FLT3 suppression rate, competitive parameters, safety (incidence of adverse events).

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	SKLB1028 150mg bid	150mg oral administration twice a day
DRUG	SKLB1028 200mg bid	200mg oral administration twice a day
DRUG	SKLB1028 300mg qd	300mg oral administration once a day

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-04-01
• Completion: 2021-06-01
• First posted: 2019-07-10
• Last updated: 2019-07-16

Locations

1 site across 1 country: China