Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer

Exclusion Criteria

• •Prior radiotherapy to the region of the study cancer or adjacent anatomical sites, or \> 25% of marrow-bearing area.
• •Prior chemotherapy for the current indication.
• •Prior therapy that specifically and directly targets EGFR, HER2 or HDAC.
• •Use of investigational agent(s) within 30 days prior to study treatment.
• •Primary tumor site of nasopharynx, sinuses, or salivary gland.
• •History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
• •Patients with prolonged QTc Interval \>450 msec.
• •Acquired Immune Deficiency Syndrome (AIDS) or known infection with human immunodeficiency virus (HIV). Testing is not required.
• •Known history of gastrointestinal bleeding, ulceration, or perforation within 6 months prior to study treatment.
• •Known history of stroke or cerebrovascular accident within 6 months prior to study treatment.
• •Symptomatic cardiac conduction abnormality within 12 months prior to study treatment.
• •Prior history of hearing impairment.
• •Known history of renal disease or ongoing renal impairment.
• •Any uncontrolled condition (such as active systemic infection, diabetes, hypertension), which in the opinion of the investigator, could affect the subjects participation in the study.
• •Prior allergic reaction to cisplatin, carboplatin or other platinum-containing compounds.
• •Central nervous system metastases.