Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Orally Administered CUDC-101 in Cancer Patients

Exclusion Criteria

• •1. Systemic anticancer therapy within 28 days prior to study treatment. Subjects with prostate cancer on LHRH hormonal therapy may be enrolled and continue on this therapy.
• •2. Use of any investigational agent(s) within 21 days prior to study treatment.
• •3. Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
• •4. Subjects receiving moderate or strong CYP3A4 or CYP2D6 inhibitors within 7 days prior to study treatment (See Appendix C for examples).
• •5. Serious infection requiring systemic antibiotic therapy within 14 days prior to study treatment.
• •6. Known gastrointestinal condition that would interfere with swallowing or the oral absorption or tolerance of CUDC-101.
• •7. Ongoing diarrhea of any grade (per NCI CTCAE v4.03).
• •8. Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis.
• •9. Unstable or clinically significant concurrent medical condition that would, in the opinion of the Investigator, jeopardize the safety of a subject and/or their compliance with the protocol.