A Study of OKI-179 in Patients With Solid Tumors

Exclusion Criteria

• •Patients meeting any of the following criteria are ineligible for enrollment in the study:
• •Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
• •Major surgery within 28 days (the surgical incision should be fully healed prior to study drug administration).
• •Radiation therapy within 21 days; however, if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient is eligible irrespective of the end date of radiotherapy. None of the recently irradiated lesions can be included in the measurable disease assessment.
• •Cytotoxic therapy within 21 days (nitrosoureas or mitomycin within 42 days, capecitabine within 14 days).
• •Monoclonal antibodies within 28 days.
• •Current use of an investigational agent that is not expected to be cleared by Cycle 1 Day 1.
• •Note: Continuation of luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer, bisphosphonates or denosumab for bone metastases.
• •Side effects from prior treatment interventions not resolved to a Grade ≤ 1 (except alopecia or peripheral neuropathy).
• •Prior Histone deacetylase (HDAC), pan-deacetylase (DAC), heat shock protein 90 (HSP90) inhibitors or valproic acid for the treatment of cancer.
• •Concomitant malignancies or previous malignancies with less than a 2-year disease free interval at the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer or others deemed to be cured by surgery alone or surgery plus radiotherapy in the judgment of the Investigator may enroll irrespective of the time of diagnosis.
• •Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study.
• •Any severe concurrent disease or condition (including active systemic infection requiring systemic therapy, uncontrolled diabetes mellitus, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, or cardiac arrhythmia) which, in the judgment of the Investigator, would make the patient inappropriate for study participation.
• •Known symptomatic active central nervous system (CNS) metastases and/or carcinomatous meningitis. Stable doses of corticosteroids for at least 2 weeks prior to enrollment for brain metastasis is allowed.
• •Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.
• •Known positive serology for the human immunodeficiency virus (HIV) (HIV 1/2 antibodies) or acquired immunodeficiency syndrome (AIDS)-related illness, and/or known active hepatitis B (e.g., hepatitis B surface antigen-reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid \[qualitative\]).
• •Pregnant or lactating females.
• •12-lead electrocardiography (ECG) demonstrating a QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≥ 480 msec for males and ≥ 480 msec for females (mean of the triplicate ECG measurements), with the exception for patients with an atrioventricular pacemaker or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
• •History or current evidence of congenital long QT syndrome.
• •Taking medications that lead to significant QT prolongation.