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RecruitingLast updated: 24 April 2024

APTIVATE: This study is evaluating how safe, tolerable and effective targeted therapy (called tuspetinib) is in people with relapsed or refractory acute myeloid leukaemiaA Phase 1/2 Open Label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Clinical summary

Summary

This study will run in three stages: dose escalation, dose exploration and dose expansion. In Part A (dose escalation), participants will receive tuspetinib daily. Dose escalation cohort is planned for up to 6 cohort levels. In Part B (dose exploration), participants will receive tuspetinib daily. Dose exploration is planned for up to 4 dose levels. Part C (dose expansion) consists of two treatment arms and participants and participants will be randomly assigned to either arm. Participants in Arm 1 will receive tuspetinib alone, daily. Participants in Arm 2 will receive tuspetinib plus venetoclax (another targeted therapy).

Conditions

This trial is treating patients with primary or secondary acute myeloid leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

APTIVATE

More information

Trial Identifiers

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Trial sponsor

Aptose Biosciences Inc.

Scientific Title

A Phase 1/2 Open Label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Eligibility

Inclusion

  • Patient is defined as having morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2016) and fulfills one of the following:

    1. Refractory to at least 1 cycle of prior therapy
    2. Relapsed after achieving remission with a prior therapy
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Patient's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), at 4 weeks for biologic or cellular immunotherapies, or at least 5 half-lives for prior experimental agents or noncytotoxic agents, including immunosuppressive therapy post hematopoietic stem cell transplantation (HSCT). (upon discussion with the Medical Monitor, shorter than stated washout period may be considered provided that the patient has recovered from any clinically relevant safety issue and recovered to Grade ≤ 1 toxicity from prior therapies)
  • Patient must meet the following criteria as indicated on the clinical laboratory tests

    1. Serum aspartate aminotransferase(AST) and alanine aminotransferase(ALT) ≤ 2.5× institutional upper limit normal (ULN)
    2. Total serum bilirubin ≤ 1.5× institutional ULN
    3. Serum creatinine ≤ 1.5× institutional ULN or an estimated glomerular filtration rate (eGFR) of > 45 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
  • Patient is suitable for oral administration of study drug and has minimum life expectancy (≥ 3 months)
  • Female patient must be either:
  • Of non-child bearing potential

    1. Post-menopausal (defined as at least 1 year without any menses) prior to screening, or
    2. Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening)
  • Or, if of childbearing potential,

    1. Must have a negative serum or urine pregnancy test at screening (within 72 hours prior to start of treatment), and
    2. Must use highly effective contraception starting at screening and throughout the study period and for 90 days after the final study drug administration.
  • Female patient must not be breastfeeding at screening and during the study period, and for 90 days after the final study drug administration
  • Female patient must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
  • Male patient and their female spouse/partners who are of childbearing potential must be using highly effective contraception starting at screening and continue throughout the study period and for 90 days after the final study drug administration.
  • Male patient must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
  • Patient agrees not to participate in another interventional study while on treatment

Exclusion

Patients must not enter the study if any of the following exclusion criteria are fulfilled.

  • Patient was diagnosed as acute promyelocytic leukemia (APL)
  • Patient has BCR-ABL-positive leukemia
  • Patient has an active malignancy other than AML, or Myelodysplastic Syndrome (MDS).
  • Patient has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery)
  • Patient has had hematopoietic stem cell transplant (HSCT) and meets any of the following:

    1. Has undergone HSCT within the 2 month period prior to the first study dose
    2. Has clinically significant graft-versus-host-disease(GVHD) requiring treatment
    3. Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant
    4. Has a donor lymphocytes infusion (DLI) ≤ 30 days prior to the first study dose or during the first two cycle of treatment on the study.
  • Patient has meningeal or central nervous system (CNS) involvement with leukemia or other CNS disease related to underlying and secondary effects of malignancy.
  • Patient has disseminated intravascular coagulation abnormality (DIC).
  • Patient has had major surgery within 4 weeks prior to the first study dose.
  • Patient has had radiation therapy within 4 weeks prior to the first study dose.
  • Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.
  • Any of the following cardiac abnormalities of history

    1. Patient has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > 250 milliseconds (ms).
    2. Patient has a mean QT interval (QTc) by Friderica's method (QTcF) > 450ms in three successive Screening measurements.
    3. Patient has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT, syndrome, family history of long QT syndrome.
    4. Patient is unable or unwilling to discontinue concomitant use of drugs that are known to prolong the QT interval.
  • Patient is known to have active infection including any identified active COVID-19 infection.
  • Patient is known to have human immunodeficiency virus infection.
  • Patient has known active hepatitis B or C, or other active hepatic disorder.
  • Patient has any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.
  • Patient has a history of Grade 3 or 4 non-hematologic toxicity related to tyrosine kinase inhibitor.

Inclusion

  • You have had treatment, but your cancer has come back.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • 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.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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

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