NCT04290325Unknown2 期
A Phase II, Single Arm, Multicenter and Open Labelstudy Evaluating the Efficacy, Safety and Pharmacokinetics of HMPL-453 in Patient With Advanced Malignant Mesothelioma
Hutchison Medipharma Limited1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年12月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is a phase II, single arm, multicenter and open-label study to evaluate the efficacy, safety and pharmacokinetic of HMPL-453 in patient with advanced Malignant Mesothelioma
详细描述
Histologically confirmed patients with advanced malignant mesothelioma that who was failure of the first -line systemic therapy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Signed written informed consent;
- •2.18 years of age or older;
- •3.Histologically diagnosed malignant mesothelioma (including pleura, peritoneum, pericardium, and testicular tendon sheath origin, cell type epithelioid, sarcoma-like, or mixed type), and cannot be cured radically;
- •4.Received one to three regimen of prior systemic therapy and then experienced documented radiographic progression or intolerable toxicity;
- •5.Patients agreed to provide tumor tissue for FGF/FGFR testing;
- •6.Measurable disease by RECIST version 1.1 criteria;
- •7.ECOG performance status ≤ 2.;
排除标准
- •1.Previous treatment with any FGFR inhibitor;
- •2.Received systemic anti-cancer therapy within 3 weeks of the first dose of HMPL-453;
- •3.Major surgery within 4 weeks of the first dose of HMPL-453;
- •4.Use of a strong inducer or inhibitor of cytochrome P450 3A4 (CYP3A4) within 1 week of the first dose of HMPL-453;
- •5.Inadequate conditions as indicated by the following laboratory values:
- •Absolute neutrophil count (ANC)<1.5 x 109/L
- •Hemoglobin < 80 g/L
- •Platelet count <80 x 109/L
- •6.Any of the following conditions of liver and kidney insufficiency:
- •Total bilirubin > 1.5 x ULN
- •AST and ALT > 2.5 x ULN (> 5 x ULN for patients with liver metastases)
- •Creatinine clearance of < 50 mL/min as estimated by the Cockcroft-Gault equation
- •7.International normalized ratio (INR) >1.5 or activated partial thromboplastin time (aPTT) >1.5 x ULN;
- •8.Clinical significant liver disease;
- •9.Known human immunodeficiency virus (HIV) infection
- •10.Previous history of retinal detachment;
- •11.Unable to swallow the study drug.
研究组 & 干预措施
HMPL-453
Experimental
HMPL-453
干预措施: HMPL-453 (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: measured up to 6 months after the last subject has been enrolled or all subjects have finished their last PFS follow up, whichever comes first
Evaluating ORR of HMPL-453 in patient with advanced malignant mesothelioma
次要结局
- Disease control rate (DCR)(measured up to 6 months after the last subject has been enrolled or all subjects have finished their last PFS follow up, whichever comes first)
- 12 weeks DCR(measured on 12 weeks)
- Time to Response (TTR)(measured on 4 weeks)
- Duration of response (DoR)(measured on 30 weeks)
- Overall survival (OS)(measured on 60weeks)
- Maximum plasma concentration (Cmax) of HMPL-453(measured on Cycle 1 day 15 and day 16)
- 12 weeks PFS(measured on 12 weeks)
- Progression free survival (PFS)(measured on 20 weeks)
- Adverse Event (AE) of HMPL-453 monitoring(Measured from the first dose to within 30 days after the end of treatment.)
- The time to Cmax (Tmax) of HMPL-453(measured on Cycle 1 day 15 and day 16)
- The area under the plasma concentration-time curve (AUC) of HMPL-453(measured on Cycle 1 day 15 and day 16)
研究者
研究点 (1)
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