Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)

Exclusion Criteria

• •1. Treatment-related AML or acute promyelocytic leukemia (APL)
• •2. Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death
• •3. Clinical evidence of active central nervous system leukemia at the time of screening
• •4. Alanine aminotransferase and/or aspartate aminotransferase ≥2.5 x upper limit of normal (ULN)
• •5. Total bilirubin \> 2.0 mg/dL (or \> 3.0 mg/dL in participants with documented Gilbert syndrome)
• •6. Serum creatinine ≥2.0 mg/dL
• •7. New York Heart Association Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition
• •8. Myocardial infarction in the previous 12 weeks (from the start of treatment)
• •9. Resting left ventricular ejection fraction \<50% at the time of screening
• •10. QT (Interval from the beginning of the QRS complex to the end of the T wave on an electrocardiogram) interval with Fridericia's correction \[QTcF\] \>450 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during screening and that result may be used to determine eligibility.
• •11. Active and uncontrolled disease (other than AML) or infection as judged by the treating physician
• •12. Treatment with systemic therapy for the primary disease within 14 days (except for hydroxyurea or isolated doses of cytarabine or decitabine for white blood cell control)
• •13. Grade 2 or greater toxicities from prior therapy, except for Grade 2 toxicities that are not expected to resolve and that in the judgment of the Investigator do not pose a significant safety risk to subject participation.
• •14. Participants with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the participant's ability to sign the informed consent form or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results.