NCT03074825终止1 期
Efficacy and Safety of Chiauranib in Relapsed/Refractory Non-Hodgkin's Lymphoma: a Single-arm, Open-label, Multi-site, Exploratory Phase Ib Study
Chipscreen Biosciences, Ltd.1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年5月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Overall response rate(ORR)
研究概览
简要总结
Chiauranib may stop the growth of tumor cells by blocking Aurora kinase B（Aurora B）、VEGFR/PDGFR/c-Kit、CSF-1R targets.
This clinical trial is studying the efficacy and safety of chiauranib works in treating patients with relapsed or refractory non-Hodgkin's lymphoma, in the meantime, exploring the latent biomarkers accompany with chiauranib, as well as the relevancy of which and clinical benefit.
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
- •Male or Female, aged ≥ 18 yrs and ≤70 yrs;
- •Histological or cytological confirmation of non-Hodgkin's lymphoma（NHL）, including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and other aggressive NHLs which determined by the investigator.
- •Patients with NHL refractory to at least 2 different chemotherapies , for which no standard therapy exists;
- •At least 1 lesion can be accurately measured, as defined by Lugano 2014 criteria.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •Subjects received anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy and surgical therapy, et al) should beyond 4 weeks prior to study entry; Subjects received mitomycin chemotherapy should beyond 6 weeks prior to study entry; Subjects received autologous stem cell transplantation should beyond 3 months prior to study entry;
- •Laboratory criteria are as follows:
- •Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets >=90×109/L Biochemistry test: total bilirubin≦1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≦1.5×ULN; (ALT,AST≦5×ULN if liver involved) ;serum creatinine(cr)≦1.5×ULN; Coagulation test: International Normalized Ratio (INR) < 1.5
- •Life expectancy of at least 12 weeks.
- •Willingness to sign a written informed consent document.
排除标准
- •Patients with prior invasive malignancies with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, unless received curative treatment and with documented evidence of no recurrence in the past five years;
- •Clinical evidence of central nervous system involvement;
- •Have uncontrolled or significant cardiovascular disease, including:
- •Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) < 50% requiring treatment with agents during screening stage.
- •primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)
- •History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 450 ms prior to study entry
- •Symptomatic coronary heart disease requiring treatment with agents
- •Uncontrolled hypertension (> 140/90 mmHg) by single agent;
- •Have active bleeding current thrombotic disease, patients with bleeding potential ,or receiving anticoagulation therapy; within 2 months prior to screening;
- •Proteinuria positive(≥1g/24h);
- •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;
- •History of organ transplantation or Allogeneic bone marrow transplantation;
- •Major surgery within 6 weeks and minor surgery within 2 weeks prior to screening (excluding placement of vascular access or biopsy) that involved general anaesthesia or respiratory assistance;
- •Serologically positive for HIV, hepatitis B or C, or other serious infectious diseases;
- •History of interstitial lung disease(ILD);
- •Previous treatment with aurora kinase inhibitors;
- •Patients appropriate and ready for autologous stem cell transplantation;
- •Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;
- •Candidate with drug and alcohol abuse;
- •Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study (both male and female participants).Pregnant or breastfeeding women. Female participants must have a negative urinary or serum pregnancy test when done or have evidence of post-menopausal status (Defined as absence of menstruation for greater than 12 months, bilateral oophorectomy or hysterectomy);
- •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 Chiauranib capsules 50mg, orally once daily, 28 days as a cycle.
干预措施: Chiauranib (Drug)
结局指标
主要结局
Overall response rate(ORR)
时间窗: assessed up to 2 years
ORR will be calculated from the data obtained from the end visit
次要结局
- time to progression(TTP)(through treatment completion, up to 2 years)
- duration of response (DOR)(assessed up to 2 years)
- overall survival(OS)(assessed up to 2 years)
- complete remission rate(CRR)(through treatment completion, up to 2 years)
- Number of participants with treatment-related adverse events(Measured through 2 years)
- progression-free survival (PFS)(assessed up to 2 years)
研究者
研究点 (1)
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