1. New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix ) within 6 months before Baseline or 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).
2. Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).
3. Uncontrolled infection.
4. Prior seizures ≥ grade-3 in CTC v.3 criteria.
5. Arsenic allergy.
6. Significant neuropathology, defined as grade \> 2 per CTCAE Version 3.0.
7. Confusion or dementia.
8. Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.
Clareo Health | Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
