Study of Oral Darinaparsin in Patients With Advanced Solid Tumors

Inclusion Criteria: * Subjects with histological or cytological confirmation of advanced cancer (solid tumor) that is refractory to standard therapies for their condition; * Men and women of ≥18 years of age; * ECOG performance score ≤2 * Eligible subjects with solid tumors MUST have at least one measurable lesion as defined by RECIST 1.1 guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST NOT have been in a previously irradiated field or injected with biological agents; * Life expectancy ≥12 weeks; * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted \<2 weeks prior to Baseline: * Creatinine ≤1.5 × upper limit of normal (ULN) OR a calculated creatinine clearance ≥50 cc/min * Total bilirubin ≤2 × ULN * Alanine transaminase (ALT) and aspartate transaminase (AST)≤3 × ULN * Granulocytes in peripheral blood ≥1 × 109/L, hemoglobin ≥10 g/dL, and platelets ≥50,000 /µL * Adequate vascular access for repeated blood sampling; * Men and women of childbearing potential must agree to use effective contraception from Screening through the duration of Study participation; * Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site. Exclusion Criteria: * Arsenic allergy. * New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix 3) within 6 months. * 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. * Pregnant and/or lactating women. * Uncontrolled systemic infection (documented with microbiological studies). * Metastatic brain or meningeal tumors. * Patients with seizure disorder requiring medication (such as anti-epileptics) * 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, Alzheimer's, and other neurological disorders. * Anticancer chemotherapy or immunotherapy during the study or within four weeks of Study entry (mitomycin C or nitrosureas should not be given within 6 weeks of Study entry) * Radiotherapy during study or within 3 weeks of Study entry. * Major surgery within 4 weeks of start of Study Drug dosing. * Other Investigational drug therapy during this trial within four weeks prior to Study entry. * 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. * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of Study results. * Any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the Study.