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

S

Sunshine Lake Pharma

Status and phase

Enrolling
Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Clifutinib Besylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT04827069
PCD-DHEC73543-16-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

80 participants in 5 patient groups

Arm 1
Experimental group
Description:
Clifutinib Besylate:10 mg
Treatment:
Drug: Clifutinib Besylate
Arm 2
Experimental group
Description:
Clifutinib Besylate:20 mg
Treatment:
Drug: Clifutinib Besylate
Arm 3
Experimental group
Description:
Clifutinib Besylate:40 mg
Treatment:
Drug: Clifutinib Besylate
Arm 4
Experimental group
Description:
Clifutinib Besylate:55 mg
Treatment:
Drug: Clifutinib Besylate
Arm 5
Experimental group
Description:
Clifutinib Besylate:70 mg
Treatment:
Drug: Clifutinib Besylate

Trial contacts and locations

0

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Central trial contact

Jie Jin, Doctor

Data sourced from clinicaltrials.gov

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