Acute myelogenous leukemia (AML)
Conditions
Interventions
Case series:MAX-40279
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males and/or females over age 18 years; 2. 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; 3. ECOG performance status of 0 to 2; 4. Expected life =3 months; 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; Acceptable renal function defined below: Serum creatinine = 1.5 times ULN or calculated creatinine clearance (by the Cockcroft-Gault formula) = 60 mL/min; 8. Acceptable coagulation status defined below: Prothrombin time < 1.3 times ULN; Partial thrombin time < 1.3 times ULN; 9. 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; 10. No receipt of any investigational drug or device within 14 days prior to screening; 11. Capable of understanding and willing to comply with the conditions of the protocol have read (patient and/or guardian).
Exclusion criteria
Exclusion criteria: 1. Disease diagnosis of acute promyelocytic leukemia; 2. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product; 3. History of drug allergy to MAX-40279; 4. 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; 5. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy; 6. Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery; 7. Percutaneous coronary intervention conducted within 6 months prior to the trial entry for cardiac infarction or angina pectoris; 8. Taking a medication that prolongs QT interval and has a risk of Torsades de Pointesor a history of long QT syndrome; 9. Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; 10. History of seizures or current use of antiepileptic medication; 11. active GVHD with clinical significance; 12. Subject is pregnant (positive serum beta human chorionic gonadotropin [ß-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; 13. History of any severe disease or abnormal in circulatory system, endocrine system, nervous system, hematology, immunology, pathergasiology, metabolic, and so on.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment-related AEs;MTD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacoketics; | — |
Countries
China
Contacts
Public ContactZhen Cai
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed