NCT02122809已完成1 期
Phase I Safety and Pharmacokinetics Study of Chiauranib in Patients With Advanced Solid Tumors
Chipscreen Biosciences, Ltd.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- dose-limiting toxicity (DLT)
研究概览
简要总结
The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chiauranib administered orally over a range of doses in patients with advanced solid tumors.
详细描述
The purpose of this study is to assess the tolerability and safety include adverse events, vital signs, laboratory tests ,etc., of a range of doses of Chiauranib in solid tumor patients, and to determine the dose limit toxicity and the maximum tolerable dose.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmation of advanced solid tumor, including non-small cell lung cancer, colorectal cancer, ovarian cancer, renal cell carcinoma, gastrointestinal stromal tumor, gastric cancer, et al;
- •Patients with advanced solid tumors refractory to standard therapy or for which no standard therapy exists;
- •Body mass index (BMI) is between 18 and 28;
- •Age: 18~65 years;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •Laboratory criteria are as follows:
- •Complete blood count: hemoglobin (Hb) ≥100g/L (no blood transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×109/L ; platelets >=100×109/L
- •Biochemistry test: serum creatinine <=1.5×upper limit of normal (ULN); total bilirubin≦1.5×ULN; alanine aminotransferase / aspartate aminotransferase≦1.5×ULN; fasting triglyceride (TG) <= 3.0 mmol/L; total cholesterol <= 7.75 mmol/L
- •Coagulation test: International Normalized Ratio (INR) < 1.5
- •Women of child-bearing potential should be non-lactating patients, and must agree to use effective contraceptive methods prior to study entry, during study participation, and up to 6 months following completion of therapy. A serum or urine pregnancy test within 7 days before enrollment must be negative; Men must agree to use effective contraceptive methods during study participation and up to 6 months following completion of therapy;
- •Willingness to sign a written informed consent document
排除标准
- •Life expectation < 3 months;
- •Subjects received anti-cancer therapy (including chemotherapy, radiotherapy, targeted therapy and endocrine therapy, et al) within 4 weeks prior to study entry; Subjects received nitrosoureas or mitomycin chemotherapy within 6 weeks prior to study entry;
- •Have uncontrolled or significant cardiovascular disease, including:
- •Myocardial infarction (< the last 12 months)
- •Uncontrolled angina (< the last 6 months)
- •Congestive heart failure (< the last 6 months), or Left Ventricular Ejection Fraction (LVEF) < 50% prior to study entry
- •History of any significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or TdP)
- •History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 450 ms prior to study entry
- •History of cerebrovascular accident
- •Symptomatic coronary heart disease requiring treatment with agents
- •Uncontrolled hypertension (> 140/90 mmHg) by single agent;
- •Have active bleeding , current thrombotic disease, or patients with bleeding potential receiving anticoagulation therapy;
- •History of deep vein thrombosis or pulmonary embolism;
- •Have unsolved toxicities (> grade 1) from prior anti-cancer therapy;
- •Have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would impair the ingestion,transportation or absorption of oral agents, or patients undergone gastrectomy;
- •Have symptomatic brain metastasis;
- •History of organ transplantation;
- •Proteinuria positive;
- •Congenital or acquired immunodeficiency, active infections;
- •Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;
- •Any other condition which is inappropriate for the study in the opinion of the investigators.
研究组 & 干预措施
Chiauranib
Experimental
Patients take a single dose of Chiauranib capsules for the pharmacokinetic study,then off for 5 days before the first cycle begins. In the subsequent treatment cycles, Chiauranib capsules are given orally once daily, 28 days as a cycle.
干预措施: Chiauranib (Drug)
结局指标
主要结局
dose-limiting toxicity (DLT)
时间窗: day 1-28
Number of Adverse Events
时间窗: An expected average of 8 months
次要结局
- pharmacokinetic profile of Chiauranib(On day 1,8,15,22,25,26,27,28)
- Pharmacodynamic profile of Chiauranib(On day 15,28)
- Evidence of benefit(An expected average of 8 months)
研究者
研究点 (1)
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