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
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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