study of oral darinaparsin in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this study is a phase i, dose escalation study of oral darinaparsin for the treatment of advanced solid tumors. eligible patients could have received any amount of previous therapy.


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.

Keywords: carcinoma sarcoma metastatic solid tumor