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

NCT04015024 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-07-16

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2021-04-30
Completion
2021-06-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04015024 on ClinicalTrials.gov