Phase I Study of Oral Darinaparsin in Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Determine Toxicity Profile
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
oral darinaparsin
open label, single arm, dose escalation
干预措施: darinaparsin (Drug)
结局指标
主要结局
Determine Toxicity Profile
时间窗: One Year
a primary outcome measure is to determine the toxicity profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
Determine Maximum Tolerated Dose
时间窗: One Year
a primary outcome measure is to determine the maximum tolerated dose of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
Determine the preliminary activity/efficacy
时间窗: One Year
a primary outcome measure is to determine the preliminary activity/efficacy of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
Determine Pharmacokinetic profile
时间窗: One Year
a primary outcome measure is to determine the pharmacokinetic profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
次要结局
未报告次要终点