Phase 1, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors

Exclusion Criteria

• •Uncontrolled central nervous system (CNS) metastasis
• •Uncontrolled concurrent illness, including active infection, angina pectoris, cardiac arrhythmia, or heart failure (NYHA class III or IV, Appendix 2 New York Heart Association (NYHA) functional classification)
• •Concurrent malignancy of a different type
• •Immunocompromised subjects, including those who are known to be infected with human immunodeficiency virus (HIV)
• •Psychiatric illness that would limit compliance with trial requirements
• •Pregnant or breast-feeding women
• •Women of childbearing potential (WOCBP) or male subjects whose partners are WOCBP who cannot or will not use effective contraceptive measures
• •Administration of another investigational agent within 6 weeks prior to start of IMP administration
• •Use of any of the prohibited medications and other substances listed in Appendix 3 CYP3A4 Inhibitors and Inducers within either 1 week prior to start of IMP administration or a period of at least 5 times the respective elimination halflife, whichever is longer
• •Known severe gastrointestinal disorder, including malabsorption (at screening)
• •Patients with CTCAE Grade 1 or higher pneumonitis (interstitial pneumonia) or pulmonary fibrosis\* \* If interstitial lung abnormalities, (e.g. ground-glass or linear opacity) are suspected on chest CT scan (high-resolution CT), regardless of whether or not there are any accompanying symptoms it must be confirmed, such as through consultation with a respiratory or radiology expert if necessary, that the patient dose not fall under this exclusion criterion before the patient can be enrolled in the trial.