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

NCT ID: NCT04827069

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-18
• Study Completion Date: 2023-08-30

Brief Summary

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.

Detailed Description

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Clifutinib Besylate:10 mg

Group Type: EXPERIMENTAL

Clifutinib Besylate

Intervention Type: DRUG

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

Arm 2

Clifutinib Besylate:20 mg

Group Type: EXPERIMENTAL

Clifutinib Besylate

Intervention Type: DRUG

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

Arm 3

Clifutinib Besylate:40 mg

Group Type: EXPERIMENTAL

Clifutinib Besylate

Intervention Type: DRUG

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

Arm 4

Clifutinib Besylate:55 mg

Group Type: EXPERIMENTAL

Clifutinib Besylate

Intervention Type: DRUG

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

Arm 5

Clifutinib Besylate:70 mg

Group Type: EXPERIMENTAL

Clifutinib Besylate

Intervention Type: DRUG

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

Arm 6

Clifutinib Besylate:100 mg

Group Type: EXPERIMENTAL

Clifutinib Besylate

Intervention Type: DRUG

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

Interventions

Clifutinib Besylate

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

Intervention Type: DRUG

Other Intervention Names

HEC73543

Eligibility Criteria

Inclusion Criteria

• Documented acute myeloid leukemia according to World Health Organization（WHO） criteria(excluding acute promyelocytic leukemia), with FLT3-ITD gene mutation,refractory after common or enhanced chemotherapy or relapse.
• ECOG performance status of 0-1.
• Subjects must have adequate organ function and meeting all of the following laboratory review before enrollment：

• Lood routine examination: WBC≤2000/mm3;
• Liver function: Alanine aminotransferase (ALT) and Aspartate transaminase (AST) ≤2.5×upper limit of normal(ULN); serum bilirubin ≤ 1.5 × ULN;
• Renal function: Serum creatinine ≤ 1.5×ULN, or the creatinine clearance (CrCl)≥ 60 mL / min calculated by the Cockcroft-Gault formula;
• Electrolyte: serum potassium≥3.0mmol/L; serum calcium≥2.0 mmol/L;serum magnesium≥0.5 mmol/L;
• Coagulation function:fibrinogen≥1.0g/L; activated partial thromboplastin time( APTT)≦ULN+10s; prothrombin time(PT)≤ULN+3s.

Exclusion Criteria

• Received FLT3 inhibitors within 4 weeks prior to the administration;
• Received hematopoietic stem cell transplantation within2 months prior to the administration or received immunosuppressor beceause of GVHD;
• Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks prior to administration;
• Nitrosourea and mitomycin chemotherapy within 6 weeks prior to the administration;
• Have taken live vaccines within 4 weeks prior to /or concurrent with the administration;
• Have received a trial investigational product, or participated in other clinical trials within 4 weeks prior to administration;
• Documented promyelocytic leukemia (t (15; 17) (q22; q11) and / or promyelocytic leukemia(PML)/retinoic acid receptor alpha (RARa) positivity found in the chromosome, variant acute promyelocytic leukemia;
• With myeloid sarcoma or invasion of central nervous system;
• NCI CTCAE 4.03 ≥ 2 grade of arrhythmia, or corrected QT interval(QTc )> 450 ms ; patients with a history of torsion or congenital QT prolonged syndrome; active infectious disease judged by the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jie Jin, Doctor

Role: STUDY_CHAIR

First Affiliated Hospital of Zhejiang University

Locations

the First Affiliated Hospital,College of Medicine,Zhejiang University

Hanzhou, , China

Countries

China

Other Identifiers

PCD-DHEC73543-16-001

Identifier Type: -

Identifier Source: org_study_id