Study to Assess the Safety & Tolerability of NOV140101(IDX-1197) in Patients With Advanced Solid Tumors

Exclusion Criteria

• •History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class
• •New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled hypertension (systolic/diastolic blood pressure \>140/90mmHg), or other clinically significant cardiovascular abnormalities in the opinion of the investigator
• •Uncontrolled cardiac arrhythmia
• •Acute coronary syndrome (unstable angina pectoris or myocardial infarction) within the past 6 months
• •Major electrocardiogram (ECG) abnormalities in the opinion of the investigator
• •Severe infection or severe traumatism
• •Pneumonia or respiratory symptoms, such as dyspnea, cough, and fever, requiring treatment and other conditions likely to be accompanied by hypoxemia
• •History of drug or alcohol abuse within the past 3 months
• •Symptomatic or uncontrolled central nervous system (CNS) metastasis
• •Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a minor surgery
• •Radiotherapy, hormone therapy, or chemotherapy within 2 weeks prior to baseline from which toxicities not recovered to ≤grade 1
• •\>4 weeks of persistent Grade 3 (NCI-CTCAE v4.03) hematologic toxicities from prior anticancer treatment
• •History of myelodysplastic syndrome (MDS) or pre-treatment cytogenetic test results indicative of the risk of MDS or acute myelocytic leukemia
• •Ongoing or anticipated treatment with antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, etc.) during the study
• •Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
• •Ongoing or past treatment with immunosuppressants within 14 days prior to the first dose of study treatment, except for intranasal, inhaled, topical, or locally injected (e.g., intraarticular injection) steroids
• •History of serious gastrointestinal bleedings within 12 weeks prior to screening or presence of diseases that may affect oral drug absorption (e.g., malabsorption syndrome, active peptic ulcer)
• •History of human immunodeficiency virus infection or active hepatitis B or C infection or ongoing uncontrolled chronic infectious disease
• •Pregnant or lactating women or patients planning to become pregnant during the study
• •Participation in another clinical trial within 30 days prior to screening
• •Individual considered ineligible for this study for other reasons, in the opinion of the investigator