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)

Sunshine Lake Pharma Co., Ltd.1 site in 1 country80 target enrollmentMay 18, 2018

ConditionsAcute Myeloid Leukemia

InterventionsClifutinib Besylate

DrugsClifutinib Besylate

Overview

Phase: Phase 1
Intervention: Clifutinib Besylate
Conditions: Acute Myeloid Leukemia
Sponsor: Sunshine Lake Pharma Co., Ltd.
Enrollment: 80
Locations: 1
Primary Endpoint: Maximum tolerated dose (MTD)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 18, 2018

End Date

March 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Sunshine Lake Pharma Co., Ltd.

Responsible Party

Sponsor

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-
•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.