NCT01931943Unknown1 期
A Phase Ib Study to Evaluate the Tolerability and Pharmacokinetics of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity(DLT)
研究概览
简要总结
Brief Description:
This study is designed to evaluate the safety and tolerability of oral Selatinib Ditosilate Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity in patients with advanced breast cancer.
详细描述
- To evaluate the safety and tolerability of oral Selatinib Ditosilate Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
- To determine the pharmacokinetic profile of single and multi oral Selatinib Ditosilate Tablets .
- To determine preliminary dose and regimen for phase II study of oral Selatinib Ditosilate Tablets.
- To assess preliminary antitumor activity .
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
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-
- •Patients with ECOG performance status of 0 or
- •Expected life-expectancy of more than 3 months.
- •Patients must have histologically or cytologically confirmed breast cancer. Either the primary breast tumor or the metastasis must overexpress HER2; acceptable methods of measurement of HER2 expression include immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH); tumors tested by IHC must be 3+ positive for HER2 overexpression immunohistochemistry ; tumors tested by FISH must be positive.
- •Prior Herceptin therapy is discontinued because of disease progression or patients can not afford for Herceptin therapy.
- •patients with at least one measurable lesion (RECIST1.1 criteria).
- •Hematology： WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥100×109/L，HB≥90g/L;
- •Biochemistry： Serum bilirubin≤1.5 times upper limit of normal (ULN),AST and ALT ≤1.5 times ULN; creatinine and urea nitrogen≤1.5 times ULN; LVEF≥50%, ECG normal, and Fridericia corrected QT(QTcF)<470ms.
- •patients receiving damage caused by other therapeutic has been restored, the interval more than six weeks since the last receiving nitroso or mitomycin; more than 4 weeks since last receiving radiotherapy, other cytotoxic drugs or surgery.
- •Subjects can swallow and have normal gastrointestinal function.
- •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.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients have uncontrolled large pleural effusion and ascites.
- •Patients have received steroid for more than 50 days, or requiring for steroid therapy for a long time.
- •Requirement for the therapeutic drugs prolonging QT interval(such as anti-arrhythmia drugs), and can not interrupt them.
- •Patients with a history of symptomatic brain metastases.
- •Patients have received small molecule targeted drug therapy of inhibition of HER-2 or EGFR.
- •Patients have participated in other drug clinical research in the past 4 weeks.
- •Pregnant or lactating women are excluded from this study.
- •Patients with a history of allergic reactions attributed to compounds of similar chemical composition to the agents used in the study are ineligible;
- •Patients with active infection ;
- •Patients with cardiac disease including Angina, any significant or need to be treated arrhythmia，Myocardial infarction, Heart failure, LVEF<45%, other heart diseases that are not suitable for participating in the study judged by investigator.
- •Patients with other concurrent severe and/or uncontrolled medical conditions （including hypertension, severe diabetes, thyroid disease, etc.) that could cause unacceptable safety risks or compromise compliance with study requirements are ineligible.
- •Patients with a history of mental disorders, including epilepsy or dementia are ineligible.
研究组 & 干预措施
Selatinib Ditosilate Tablets
Experimental
Selatinib Ditosilate either at 450,750,1000,1250mg, p.o. once daily
干预措施: selatinib ditosilate tablets (Drug)
结局指标
主要结局
Dose-limiting toxicity(DLT)
时间窗: 21 days
Maximum tolerated dose(MTD)
时间窗: 21 days
次要结局
- Pharmacokinetics(21 days)
- Pharmacodynamics(7 weeks)
研究者
研究点 (1)
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