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receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days

Clifutinib Besylate

Jie Jin, Doctor

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Clifutinib Besylate in Relapsed/refractory AML patients with FLT3-ITD mutation.

It is a multi-center , open-label, single arm study conducted in 2 parts. Dose-escalation part: Subjects will receive oral Clifutinib Besylate once on C0D1.After 3 days,they will receive Clifutinib Besylate once daily repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days.

Expansion part:Expansion cohort might be set to further investigate the safety and efficacy of Clifutinib Besylate at or lower MTD dose recommended by dose-escalation part.

Arm 1:10 mg Arm 2:20 mg Arm 3:40 mg Arm 4:55 mg Arm 5:70 mg

A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML)

A Phase I, Multi-center, Open,Single Arm, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Clifutinib Besylate(HEC73543) in Relapsed or Refractory Acute Myeloid Leukemia (AML)

Safety and Tolerability assessed through adverse events to determine maximum tolerated dose

to assess the pharmacokinetic profile in patients with AML

The time from receive CR / CRi/CRMRD-/PR to relapse

From the first time taking experimental drug to treatment failure or progression or relapse or death

From the first time taking experimental drug to death

Sunshine Lake Pharma Co., Ltd.

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Azacitidine

Daunorubicin

Queue 1:Clifutinib Besylate:30mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:30mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7

Queue 1:Clifutinib Besylate:40mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:40mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7

Queue 1:Clifutinib Besylate:60mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:60mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7

The queue 1 is divided into Induction therapy and Consolidation therapy and Maintenance treatment The queue 2 will receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs

This is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AML

Main purpose:To evaluate the tolerability and safety of Clifutinib Besylate combined with DA (Cytarabine + Daunorubicin) or AZA (Azacitidine) in newly-treated adult AML subjects; explore reasonable therapeutic doses through climbing tests in different dose groups.

To evaluate the efficacy of Clifutinib Besylate combined with DA or AZA in newly treated adult AML subjects.

Secondary purpose:To observe the pharmacokinetic (PK) characteristics of Clifutinib combined with DA or AZA in newly-treated adult AML subjects and the drug interaction between Clifutinib and AZA at the same time.Observe the correlation of different subtypes and prognostic risk with the efficacy of Clifutinib and the changes of genes before and after treatment.

A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML

A Phase Ib/II, Multi-center, Open Clinical Trial of Crifortinib Besylate Combined With Chemotherapy in Newly-treated Adult Subjects With Acute Myeloid Leukemia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML)	NCT04827069	Acute Myeloid L...	Clifutinib Besy...	18 Years -	Sunshine Lake Pharma Co., Ltd.
A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML)	NCT04827069	Acute Myeloid L...	Clifutinib Besy...	18 Years -	Sunshine Lake Pharma Co., Ltd.
A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML	NCT05133882	Acute Myeloid L...	Clifutinib Besy...	18 Years -	Sunshine Lake Pharma Co., Ltd.

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