NCT01806376Unknown1 期
A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity， maximum tolerated dose.
研究概览
简要总结
- purpose: to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study
- Experimental Design： A phase Ⅰ study of single-center
- Test drug: Subutinib Maleate capsules
- Sample size≥20
详细描述
The primary objective of this study is to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study, to investigate the pharmacokinetics of single and multiple oral doses of Subutinib Maleate capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have histologically or cytologically confirmed solid tumors
- •Subjects who have failed standard effective therapy or have a diagnosis for which no standard effective treatment is available;
- •Aged 18 to 70 years old; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; Life expectancy greater than 3 months;
- •If the subject has been given other chemotherapy drugs, it's necessary to discontinue them more than 4 weeks. If the chemotherapy drugs are Nitrosoureas and Mitomycin C, it's necessary to discontinue them more than 6 weeks. If the subject has accepted major surgery, it's necessary to wait more than 4 weeks before the subject participating in this study.
- •Blood test: Hb≥100g/L(no blood transfusion within 14 days); ANC≥1.5×109/L, PLT≥100×109/L
- •Biochemistry: TBIL and ALT and AST and Cr are in normal range, or creatinine clearance ≥60ml/min; Triglyceride≤3.0mmol/L; Cholesterol ≤7.75mmol/L.
- •Doppler ultrasound measurement: LVEF ≥ LLN
- •Female subjects should agree to take contraceptives during the study and within 6 months after the study (such as intrauterine device [IUD], contraceptive drugs or condoms); within 7 days before they enter the study, their serum or human chorionic gonadotropin should be negative, and must be in the non-lactation period; male subjects should agree to take contraceptives during the study and within 6 months after the study.
- •The subject is willing to participate in this study, and he/she has signed the Informed Consent Form, with good compliance.
排除标准
- •The subject has participated in other drug clinical research in the past 4 weeks.
- •The subject is accompanied with several factors which will influence the investigational drug administration orally, such as inability to swallow or after gastrointestinal resection or chronic diarrhea or intestinal obstruction.
- •Central nervous system metastasis definitely.
- •The subject is suffering from hypertension or myocardial ischemia or myocardial infarction or arrhythmia (including QT interval≥440ms) or Grade I heart failure.
- •If the subject's systolic BP is over 140mmhg, with diastolic BP over 90mmhg, or the subject's blood pressure is well-controlled, he/she is not permitted to enroll in this study as well.
- •The subject's urinalysis displays that urinary protein ≥ ++ , combined with 24-hour urinary protein > 1.0g.
- •The subject's is suffering from wounds or fractures which can not be cured for long time.
- •Abnormal coagulation: The subject has bleeding tendency such as active peptic ulcer or the subject is receiving thrombolytic or anticoagulant therapy.
- •There are pre-dosing arterial/venous thrombotic events on this subject, such as cerebrovascular accident (including TIA) or deep vein thrombosis or pulmonary embolism.
- •The subject is accepting anticoagulants or vitamin K antagonists such as warfarin or heparin or analogue therapy; If the subject's INR ≤ 1.5, he/she is allowed to use small doses of warfarin (1mg oral q d) or small doses of aspirin(less than 100mg each day), and the purpose of the treatment should be prevention.
- •Abnormal thyroid function.
- •There is history of mental drug abuse occurred in the subject, or the subject is suffering from mental disorders.
- •There is history of immunodeficiency occurred in the subject, including HIV positive or other acquired or congenital immunodeficiency diseases, or the subject has accepted organ transplant before.
- •Lung squamous cell carcinoma.
- •The subject has received small molecule targeted drug therapy of inhibition of VEGFR-2 and PDGFRβ
- •According to the investigator's judgment, there are concomitant diseases which will seriously do harm to the subject's safety or obstruct the subject to complete the study.
研究组 & 干预措施
Subutinib Maleate capsules
Experimental
Dose escalation will be dependent on any dose limiting toxicities
干预措施: Subutinib Maleate capsules (Drug)
结局指标
主要结局
Dose-limiting toxicity， maximum tolerated dose.
时间窗: 2 months
次要结局
- Pharmacokinetics(2 months)
- Pharmacodynamics(2 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study Of SU011248 In Combination With Docetaxel In Patients With Advanced CancerAdvanced Solid TumorsNon Small Cell Lung CancerNCT00712504Pfizer49
已完成
1 期
A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)Gastrointestinal Stromal TumorsNCT00457743Pfizer36
已完成
1 期
Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell CarcinomaCarcinoma, Renal CellNCT00113529Pfizer42
已完成
1 期
Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric CancerStomach NeoplasmsNCT00555672Pfizer34
已完成
1 期
Study Of Sunitinib With S-1 And Cisplatin For Gastric CancerStomach NeoplasmsNCT00553696Pfizer27