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Last Updated: May 6, 2024

CLINICAL TRIALS PROFILE FOR SKLB1028

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Clinical Trials for SKLB1028

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02859948 ↗	A Study of SKLB1028 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia	Unknown status	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1	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.
NCT04015024 ↗	A Clinical Study of SKLB1028 Capsule in the Treatment of Recurrence/Refractory AML Patients	Unknown status	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 2	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.
NCT04716114 ↗	A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated	Recruiting	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 3	This is a randomized，multicenter, open-label Phase III, clinical study to confirm the efficacy and safety of SKLB1028 in patients with relapsed or refractory(R/R) FLT3-Mutated Acute Myeloid Leukemia（AML）compared to salvage chemotherapy.
NCT05069870 ↗	A Study to Investigate the Drug-drug Interactions (DDIs) of SKLB1028 With Itraconazole, Gemfibrozil or Rifampicin in Healthy Subjects	Active, not recruiting	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1	This is a three-part, single-center, open-label phase I clinical study to characterize the DDIs potential of SKLB1028 with Itraconazole, Gemfibrozil or Rifampicin in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Itraconazole, Gemfibrozil or Rifampicin.
NCT05070195 ↗	A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects	Completed	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1	This is a single-center, open-label phase I clinical study to investigate the effect of SKLB1028 on the pharmacokinetics of Midazolam and its metabolite 1'-OH-midazolam in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Midazolam.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Summary

Clinical Trial Conditions for SKLB1028

Condition Name

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Condition Name for
Intervention	Trials
Healthy Subjects	3
Acute Myeloid Leukemia	2
Healthy Male Subjects	1
Newly Diagnosed Acute Myeloid Leukemia (AML)	1
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Condition MeSH

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Condition MeSH for
Intervention	Trials
Leukemia, Myeloid	4
Leukemia, Myeloid, Acute	4
Leukemia	3
Neoplasms	1
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Clinical Trial Locations for SKLB1028

Trials by Country

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Trials by Country for
Location	Trials
China	9
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Clinical Trial Progress for SKLB1028

Clinical Trial Phase

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Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1/Phase 2	1
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Clinical Trial Status

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Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	3
Recruiting	2
Unknown status	2
[disabled in preview]	2
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Clinical Trial Sponsors for SKLB1028

Sponsor Name

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Sponsor Name for
Sponsor	Trials
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	9
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Sponsor Type

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Sponsor Type for
Sponsor	Trials
Industry	9
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