A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment

Korábbi kezelés

• Gastrointestinal Disease (GI) within previous 6 months.
• Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.

Más betegség

• Uncontrolled active infection of any type. Infections under control with antibiotic treatment are acceptable for study entry.
• Uncontrolled invasive fungal infection (positive blood or tissue culture).

Laborértékek

• QT interval corrected for heart rate using Fridericia's formula (QTcF) of \>450 millisecond (ms) (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
• Participants requiring the concurrent use of medications known or suspected to prolong the QT/QTc interval, with the exception of drugs with low risk of QT/QTc prolongation that are used as standard supportive therapies (for example, diphenhydramine, famotidine, ondansetron, Bactrim) and the azoles permitted.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

• Documented active diagnosis of R/R hematologic malignancy (for example, R/R acute leukemias \[acute myeloblastic leukemia \[AML\]/acute lymphoblastic leukemia \[ALL\] or mixed phenotype acute leukemia \[MPAL\]) in medically stable individuals based on their medical history and clinical evaluation who may benefit from revumenib as determined by the Investigator.
• Hepatic and renal function as indicated by clinical chemistry values.
• Adequate cardiac function defined as ejection fraction ≥50% by echocardiogram or multigated acquisition (MUGA) scan.
• Potassium maintained at ≥4.0 milliequivalent/liter (mEq/L) and magnesium at ≥2.0 milligram/deciliter (mg/dL).
• White blood cell (WBC) must be \< 25,000/microliter (µL) prior to the first dose of revumenib.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤2 at Screening. (For participants ≥65 years of age, an ECOG PS score of 0 or 1.)