Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)

Inclusion Criteria

• A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.
• AML that is refractory to or relapsed after standard induction therapy.
• Age ≥18 years at the time of signing informed consent.
• No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.
• No investigational therapy within four weeks of the first dose of study drug.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
• Adequate laboratory results including the following:
• Bilirubin ≤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome
• Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase 480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.
• Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant, lactating, or not using adequate contraception.
• Known allergy to anthracyclines.
• Any evidence of mucositis/stomatitis or previous history of severe (≥Grade 3) mucositis from prior therapy.
• Required use of strong inhibitors and inducers of CYP enzymes and transporters.