MEK Inhibitor MEK162, Idarubicin, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Exclusion Criteria

• •Concomitant treatment with other anti-neoplastic agents, with the exception of hydroxyurea
• •Anti-neoplastic treatment less than 14 days prior to enrollment, with the exceptions of hydroxyurea or, in the case of a patient with primary refractory AML, prior induction chemotherapy
• •Prior therapy with a MEK inhibitor
• •Uncontrolled opportunistic infection or treatment for opportunistic infection within 4 weeks of first day of study drug dosing
• •Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to MEK162, anthracycline, or cytarabine
• •Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of MEK162 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
• •Previous or concurrent malignancy with the following exceptions:
• •* Carcinoma in situ
• •* Adequately treated skin basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)
• •* In situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to the study
• •* A primary malignancy which has been completely resected and in complete remission for \>= 5 years
• •Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
• •* History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting \[CABG\], coronary angioplasty, or stenting) \< 6 months prior to screening
• •* Symptomatic chronic heart failure
• •* Evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities \< 6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia
• •Uncontrolled arterial hypertension despite appropriate medical therapy
• •Patients who have neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
• •Known confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis (hepatitis B or hepatitis C)
• •Any surgical procedure, excluding central venous catheter placement, bone marrow biopsy, lumbar puncture, or other minor procedures (e.g., skin biopsy) within 14 days of day 1; patients who have undergone major surgery =\< 21 days prior to starting study drug or who have not recovered from side effects of such procedure are ineligible for the study
• •Pregnant or nursing (lactating) women confirmed by a positive hCG laboratory test
• •* Women of child-bearing potential unless they are using highly effective methods of contraception throughout the study and for 30 days after study drug discontinuation
• •Sexually active males unless they use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
• •Unwillingness or inability to comply with the protocol
• •Known active leukemia of the central nervous system
• •Known history of Gilbert's syndrome
• •History or current evidence of retinal pigment epithelial detachment (RPED), retinal vein occlusion (RVO), or predisposing factors to RPED or RVO (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled diabetes mellitus, hyperviscosity or hypercoagulability syndromes)
• •History of retinal degenerative disease