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

NCT04827069 | Completed Phase 1

• 1 other identifier: PCD-DHEC73543-16-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

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

  day 1-28

Secondary Outcomes (8)

• Maximum observed plasma concentration (Cmax)

  On day 1,8,15,22,28

• Time of maximum observed plasma concentration (Tmax)

  On day 1,8,15,22,28

• Area under the plasma concentration time curve

  On day 1,8,15,22,28

• Composite CR rate

  up to 18 months

• Duration of response

  up to 18 months

Study Arms (6)

Arm 1

EXPERIMENTAL

Clifutinib Besylate:10 mg

Drug: Clifutinib Besylate

Arm 2

EXPERIMENTAL

Clifutinib Besylate:20 mg

Drug: Clifutinib Besylate

Arm 3

EXPERIMENTAL

Clifutinib Besylate:40 mg

Drug: Clifutinib Besylate

Arm 4

EXPERIMENTAL

Clifutinib Besylate:55 mg

Drug: Clifutinib Besylate

Arm 5

EXPERIMENTAL

Clifutinib Besylate:70 mg

Drug: Clifutinib Besylate

Arm 6

EXPERIMENTAL

Clifutinib Besylate:100 mg

Drug: Clifutinib Besylate

Interventions

Clifutinib Besylate DRUG

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

Also known as: HEC73543

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

the First Affiliated Hospital,College of Medicine,Zhejiang University

Hanzhou, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jie Jin, Doctor

  First Affiliated Hospital of Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm 1:10 mg Arm 2:20 mg Arm 3:40 mg Arm 4:55 mg Arm 5:70 mg Arm 6: 100 mg

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 1, 2021
• Study Start: May 18, 2018
• Primary Completion: August 21, 2023
• Study Completion: August 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)