NCT02590952已完成1 期
An Open-label, Multi-Centered, Dose Escalation Phase Ib Study (Expansion Stage) of Epitinib (HMPL-813) in Patients With Advanced Solid Tumors
Hutchison Medipharma Limited1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2011年10月31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
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- incidence of all types/grades of adverse events
研究概览
简要总结
Epitinib (HMPL-813) is a selective EGFR tyrosine kinase inhibitor. Epitinib has demonstrated strong inhibitory effects on multiple tumors with overexpressed EGFR or sensitive EGFR mutations in pre-clinical setting. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of Epitinib.
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
- •Histopathology confirmed solid tumors
- •Failed to standard treatment or no standard treatments for uncontrolled, recurrent and/or metastatic advance tumor (whatever previous surgery conditions)
- •Age 18-70
- •ECOG 0-2, and no worse within 7days
- •Life expected > 12 weeks
- •written informed consent form voluntarily
- •For dose expansion cohort, subjects must be eligible for the following inclusion criteria:
- •EGFR sensitizing mutation in exon 19 deletion or exon 21(L858R).
- •Histologically or cytologically confirmed advanced NSCLC with brain metastasis. No prior brain radiotherapy or brain metastasis progressed after brain radiotherapy delivered assessed by RECIST 1.
- •No prior EGFR-TKI treatment. Or subjects who treated with EGFR-TKI developed brain lesions during EGFR-TKI therapy or the existing brain lesions progressed but with stable extra-cranial lesions.
- •Treatment failure of prior systemic chemotherapy for locally advanced or metastasized NSCLC or intolerance to chemotherapy. Or subjects with disease relapse after treated with adjuvant or neo-adjuvant chemotherapy.
- •With at least one measurable disease ( RECIST 1.1).
排除标准
- •Lab testing within 2 weeks before enrolled, AND ANC<1.5×10 9/L, platelet<75×10 9/L, or Hb<9g/dL,
- •Serum Total Bilirubins > ULN, ALT/AST≥ULN without liver metastasis, or ALT/AST≥2.5ULN with liver metastasis
- •Serum creatinine >1.5ULN or creatinine clearance <40ml/min
- •Diastolic systolic pressure≥140mmHg or systolic diastolic pressure≥90mmHg whatever anti-hypertension drug used,
- •Serum potassium <4.0mmol/L(whenever potassium implemented), serum calcium(ionic or albumin-type calcium) or serum magnesium outside normal ranges(whenever implemented)
- •Within previous 4 weeks treated by systemic anti-tumor therapy, or radiotherapy, immune therapy, biological or hormonal therapy, and clinical trials.
- •Unrecovered from any previous therapy related toxicity to CTCAE 0 or 1or unrecovered from any previous surgery
- •Known dysphagia or drug malabsorption
- •Active infections such as acute pneumonia, hepatitis B immune-active periodphase
- •ocular surface diseases or dry eye syndrome
- •skin disease with obvious symptoms and signs
- •significant cardiovascular disease, including II-IV atrioventricular block, and acute myocardial infarction within 6 months, significant angina or Coronary artery bypass graft within 6 months
- •Female patients who are pregnant or feeding, or childbearing potential patient with pregnant testing positive
- •Any abnormal of clinical and laboratory so that patients unsuitable to attend the trial sine in the opinion of the investigator
- •Patients unable to comply with the protocol since significant psychological or psychogenic abnormal
研究组 & 干预措施
Epitinib
Experimental
Epitinib is a capsule in the form of 5mg,20 mg, and 40 mg. Route: oral (daily)
干预措施: Epitinib (Drug)
结局指标
主要结局
incidence of all types/grades of adverse events
时间窗: from first patient in till 30 days after the last patient last visit. It is estimated that last patient last visit happens in Oct 2016.
for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation
次要结局
- Objective Response Rate(An average of one year)
- Area under the plasma concentration versus time curve (AUC)(At single-dose stage (day 1-day 7): predose, 0.5,1, 2, 3, 4, 5, 6, 8,12,24, 36, 48, 72, 144 hours post-dose.)
- Peak Plasma Concentration (Cmax)(At single-dose stage (day 1-day 7): predose, 0.5,1, 2, 3, 4, 5, 6, 8,12,24, 36, 48, 72, 144 hours post-dose.)
研究者
研究点 (1)
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