Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas

Exclusion Criteria

• •1. New York Heart Association (NYHA) functional class ≥3 myocardial infarction within 6 months
• •2. Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥Grade 2 atrioventricular (AV) block or left bundle branch block (LBBB); or documented history of prolonged QTc.
• •3. Pregnant and/or lactating women.
• •4. Uncontrolled systemic infection (documented with microbiological studies).
• •5. Metastatic brain or meningeal tumors.
• •6. Subjects with seizure disorder requiring medication (such as anti-epileptics).
• •7. History of confusion or dementia or neurological condition that could mask a potential adverse response to the Study Drug, which may include transient ischemic attack, Parkinson's disease, thrombotic or hemorrhagic stroke, Alzheimers, and other neurological disorders.
• •8. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of Study entry (mitomycin C or nitrosureas should not be given within 6 weeks of Study entry).
• •9. Radiotherapy during study or within 3 weeks of Study entry.
• •10. Surgery within 4 weeks of start of Study Drug dosing.
• •11. Investigational drug therapy outside of this trial during or within 4 weeks of Study entry.
• •12. History of invasive second primary malignancy diagnosed within the previous 3 years except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.
• •13. Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of Study results.
• •14. Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance in the Study.
• •15. Arsenic allergy.