Clinical trial NCT01139346 (phase 1, status: completed)
Conditions: advanced solid tumors
ICD codes: K74.02, G47.22, H35.3133, H35.3134, H35.3113, H35.3114, H35.3123
Drugs: darinaparsin
SMILES: C[As](C)SC[C@H](NC(=O)CC[C@H](N)C(O)=O)C(=O)NCC(O)=O
Eligibility criteria:

        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.