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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04827069
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Sunshine Lake Pharma Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Clifutinib Besylate Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Arm 1:10 mg Arm 2:20 mg Arm 3:40 mg Arm 4:55 mg Arm 5:70 mg
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : October 8, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Clifutinib Besylate:10 mg
 Drug: Clifutinib Besylate
receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days
Other Name: HEC73543
Experimental: Arm 2
Clifutinib Besylate:20 mg
 Drug: Clifutinib Besylate
receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days
Other Name: HEC73543
Experimental: Arm 3
Clifutinib Besylate:40 mg
 Drug: Clifutinib Besylate
receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days
Other Name: HEC73543
Experimental: Arm 4
Clifutinib Besylate:55 mg
 Drug: Clifutinib Besylate
receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days
Other Name: HEC73543
Experimental: Arm 5
Clifutinib Besylate:70 mg
 Drug: Clifutinib Besylate
receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days
Other Name: HEC73543


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: day 1-28 ]
    Safety and Tolerability assessed through adverse events to determine maximum tolerated dose


Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: On day 1,8,15,22,28 ]
    to assess the pharmacokinetic profile in patients with AML

  2. Time of maximum observed plasma concentration (Tmax) [ Time Frame: On day 1,8,15,22,28 ]
    to assess the pharmacokinetic profile in patients with AML

  3. Area under the plasma concentration time curve [ Time Frame: On day 1,8,15,22,28 ]
    to assess the pharmacokinetic profile in patients with AML

  4. Composite CR rate [ Time Frame: up to 18 months ]
    CR + CRi +CRMRD-

  5. Duration of response [ Time Frame: up to 18 months ]
    The time from receive CR / CRi/CRMRD-/PR to relapse

  6. Objective response rate [ Time Frame: up to 18 months ]
    CR + CRi +CRMRD- + PR

  7. Event Free Survival [ Time Frame: up to 18 months ]
    From the first time taking experimental drug to treatment failure or progression or relapse or death

  8. Overall Survival [ Time Frame: up to 18 months ]
    From the first time taking experimental drug to death


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827069


Contacts
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Contact: Jie Jin, Doctor 0571-87236685 jiej0503@163.com

Locations
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China
the First Affiliated Hospital,College of Medicine,Zhejiang University Recruiting
Hanzhou, China
Contact: Jie Jin, Doctor    0571-87236685    jiej0503@163.com   
Sponsors and Collaborators
Sunshine Lake Pharma Co., Ltd.
Investigators
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Study Chair: Jie Jin, Doctor First Affiliated Hospital of Zhejiang University
More Information
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Responsible Party: Sunshine Lake Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04827069    
Other Study ID Numbers: PCD-DHEC73543-16-001
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms