NCT01416623终止1 期
A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The maximum-tolerated dose (MTD) regimen of henatinib will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) after completing one treatment cycle.
研究概览
简要总结
Henatinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activities. This study is designed to evaluate the safety and tolerability of Henatinib in patients with Advanced Solid Malignancies
详细描述
- To evaluate the safety and tolerability of Henatinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
- To determine the pharmacokinetic profile of Henatinib and its metabolites .
- To assess preliminary antitumor activity .
- To determine preliminary regimen for phase II study .
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologic (except sputum smear) confirmed metastatic or locally advanced solid tumor (At least one measurable lesion longest diameter ≥20 mm using conventional techniques or larger than 10 mm in diameter by spiral CT scan).
- •Life expectancy of more than 12 weeks.
- •Lack of standard treatment or standard treatment failure.
- •Screening laboratory values within the following parameters:
- •ANC:≥1.5×109/L
- •PLT:≥100×109/L
- •ALT and AST:≤1.5×ULN(But if the liver metastases, ALT and AST:≤5×ULN)
- •Serum total bilirubin:≤1.5×ULN
- •Serum creatinine:≤1.5×ULN
- •Creatinie clearance rate:≥60ml/min
- •Electrolytes normal or return to normal after treatment
- •Recovery from all clinically significant AEs related to prior therapies. Duration from the latest therapy is more than 6 weeks for nitroso or mitomycin, or more than 4 weeks for radiotherapy, chemotherapy, immunotherapy or other anti-cancer treatments (such as testing drugs, biologics, hormones or surgery).
- •Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
排除标准
- •Evidence of CNS metastasis.
- •Major surgery, open biopsy, or obvious trauma within 4 weeks before treatment.
- •Obvious peritoneal implantation or pelvic obstruction.
- •II level or above, peripheral neuropathy (NCI CTC AE v3.0).
- •Known history of neurological or psychiatric disease.
- •Suffering from high blood pressure and can not be reduced to the following range by monotherapy (systolic blood pressure <140 mmHg, diastolic blood pressure <90 mmHg).
- •History of heart disease:> NYHA II class congestive heart failure; unstable coronary artery disease (patients who had last myocardial infarction 12 months before can be enrolled), arrhythmias - requires antiarrhythmic drug therapy. Bazett's corrected QTc ≥ 480 ms or can not be measured. (Note: If ECG QTc interval ≥ 480 ms during the screening period, you must repeat 2 times, separated by at least 24 hours, the average QTc of the 3 times must be <480 s, the patient can be enrolled in this study) .
- •Coagulopathy (PT> 16 s, APTT> 43 s, TT> 21 s, Fbg <2 g / L), with a bleeding tendency or are receiving the therapy of thrombolysis or anticoagulation.
- •Confirmed active gastrointestinal ulcers.
- •Active severe infection (> NCI-CTC 3.0 standard 2).
- •Patients with severe epilepsy requires drug treatment (such as steroids or anti-epileptic drugs).
- •Other serious illness or condition.
- •Treated with VEGFR TKIs such as sunitinib or solafenib before study entry.
- •Less than 4 weeks from the last clinical trial.
- •Pregnancy, breast-feeding women or women of childbearing age without effective contraception.
- •Allergic or known history of hypersensitivity to henatinib or any of it components.
- •Drug abuse, the drug and mental illness may affect the patients participation in this study and the assessment of the research results.
- •Any unstable or likely situation that harms the safety and compliance of the patients in this study.
- •Any factors that influence the usage of oral administration.
- •Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
研究组 & 干预措施
Henatinib
Experimental
Henatinib either at 12.5,25,37.5,50,62.5,75,87.5 or 100 mg, p.o. once daily
干预措施: henatinib (Drug)
结局指标
主要结局
The maximum-tolerated dose (MTD) regimen of henatinib will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) after completing one treatment cycle.
时间窗: 4 weeks
次要结局
- Number of participants with adverse events(8 weeks)
- Henatinib pharmacokinetic parameters may include AUC, Cmax, Tmax, and t1/2.(4 weeks)
- Objective response rate (ORR)(8 weeks)
研究者
研究点 (1)
Loading locations...
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