Last updated: January 18, 2022
Sponsor: Maxinovel Pty., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Leukemia
Acute Myelogenous Leukemia (Aml)
Treatment
N/AClinical Study ID
NCT03412292
Maxinovel
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and/or females over age 18
- Ability to understand the purposes and risks of the trial and signed informed consentforms approved by the investigator's Institutional Review Board (IRB)/IndependentEthics Committee (IEC) of the trial site was obtained before the entering the trial
- Subject has morphologically documented primary AML or AML secondary to myelodysplasticsyndrome (MDS) as defined by the World Health Organization (WHO) criteria for which noestablished standard therapy is available
- ECOG performance status of 0 to 2
- Persistent chronic clinically significant nonhematological toxicities from priortreatment (including chemotherapy, kinase inhibitors, immunotherapy, experimentalagents, 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 priornoncytotoxic 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 timesULN;
- Acceptable renal function defined below: • Serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance (by theCockcroft-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 lactatingduring the study and for three months following the last dose of study drug. Both menand women of reproductive potential must agree to use a highly effective method ofbirth control during the study and for three months following the last dose of studydrug. A highly effective method of contraception is defined as one that results in alow failure rate, i.e., less than 1% per year, when used consistently and correctly
Exclusion
Exclusion Criteria:
- Disease diagnosis of acute promyelocytic leukemia
- Previously treated malignancies other than the current disease, except for adequatelytreated non-melanoma skin cancer, in situ cancer, or other cancer from which thesubject has been disease-free for at least 5 years at the trial entry
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemictherapy
- 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 entryfor 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,ora history of long QT syndrome
- Medical history of difficulty swallowing, malabsorption or other chronicgastrointestinal disease, or conditions that may hamper compliance and/or absorptionof the tested product
- Participation in an investigational drug or device trial within 4 weeks prior to thetrial 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 bleedingdiathesis
- Subject is pregnant (positive serum beta human chorionic gonadotropin [β-HCG] test atscreening) or is currently breast-feeding, their partner anticipates becomingpregnant/impregnating during the trial or within 6 months after receiving the lastdose 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 thesubject 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, includingcongestive heart failure, myocardial infarction within 6 months prior to the trialentry, unstable arrhythmia, or symptomatic peripheral arterial vascular
Study Design
Total Participants: 30
Study Start date:
August 01, 2018
Estimated Completion Date:
December 01, 2022
Study Description
Connect with a study center
St Vincent's Hospital Sydney Limited
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Western NSW Local Health District
Dubbo, New South Wales 2830
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria 3168
AustraliaActive - Recruiting
Austin Health
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
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