Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Males and/or females over age 18
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
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
ECOG performance status of 0 to 2
Persistent chronic clinically significant nonhematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1
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

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;

Acceptable renal function defined below:

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

Acceptable coagulation status defined below:

Prothrombin time < 1.3 times ULN
Partial thrombin time < 1.3 times ULN
No clinically significant abnormalities in urinalysis
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 Criteria:

Disease diagnosis of acute promyelocytic leukemia
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
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery
Percutaneous coronary intervention conducted within 6 months prior to the trial entry for cardiac infarction or angina pectoris
Seizure disorders requiring anticonvulsant therapy
Taking a medication that prolongs QT interval and has a risk of Torsades de Pointes，or a history of long QT syndrome
Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
Participation in an investigational drug or device trial within 4 weeks prior to the trial entry
Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within 1 year of study)
History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis
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
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
Unwillingness or inability to comply with the trial protocol for any reason
Legal incapacity or limited legal capacity
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