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RecruitingLast updated: 16 April 2024

MAX-40279-001: This phase I trial is testing a new oral drug (MAX-40279) for the treatment of Acute Myelogenous Leukaemia (AML)A Phase I Trial of MAX-40279 Given Orally to Subjects With Acute Myelogenous Leukemia (AML)

Clinical summary

Summary

MAX-40279 is a dual inhibitor of FLT3 and FGFR. The aim of this trial is to develop this unique dual inhibitor to be more effective and in wider use for AML treatment than the current known FLT3 inhibitors. MAX-40279 will be provided as a capsule for oral use at 5mg, 25mg.

Conditions

This trial is treating patients with Acute Myelogenous Leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

MAX-40279-001

More information

Trial Identifiers

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Trial sponsor

Maxinovel Pty., Ltd

Scientific Title

A Phase I Trial of MAX-40279 Given Orally to Subjects With Acute Myelogenous Leukemia (AML)

Eligibility

Inclusion

  1. Males and/or females over age 18
  2. Ability to understand the purposes and risks of the trial and signed informed consent forms approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of the trial site was obtained before the entering the trial
  3. Subject has morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS) as defined by the World Health Organization (WHO) criteria for which no established standard therapy is available
  4. ECOG performance status of 0 to 2
  5. Persistent chronic clinically significant nonhematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1
  6. In the absence of rapidly progressing disease clearly documented by the investigator, the interval from prior treatment to time of MAX-40279 administration will be at least 2 weeks (14 days) for prior cytotoxic agents or at least 5 half-lives for prior noncytotoxic agents, including immunosuppressive therapy post HSCT
  7. Acceptable liver function defined below:

    • Total bilirubin ≤ 1.5 times upper limit of normal range (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times ULN;
  8. Acceptable renal function defined below:

    • Serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance (by the Cockcroft-Gault formula) ≥ 60 mL/min

  9. Acceptable coagulation status defined below:

    • Prothrombin time < 1.3 times ULN
    • Partial thrombin time < 1.3 times ULN
  10. No clinically significant abnormalities in urinalysis
  11. Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly

Exclusion

  1. Disease diagnosis of acute promyelocytic leukemia
  2. Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry
  3. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  4. Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery
  5. Percutaneous coronary intervention conducted within 6 months prior to the trial entry for cardiac infarction or angina pectoris
  6. Seizure disorders requiring anticonvulsant therapy
  7. Taking a medication that prolongs QT interval and has a risk of Torsades de Pointes,or a history of long QT syndrome
  8. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
  9. Participation in an investigational drug or device trial within 4 weeks prior to the trial entry
  10. Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  11. Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within 1 year of study)
  12. History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis
  13. Subject is pregnant (positive serum beta human chorionic gonadotropin [β-HCG] test at screening) or is currently breast-feeding, their partner anticipates becoming pregnant/impregnating during the trial or within 6 months after receiving the last dose of trial treatment
  14. Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial
  15. Unwillingness or inability to comply with the trial protocol for any reason
  16. Legal incapacity or limited legal capacity
  17. Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular

Inclusion

  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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