NCT04510415终止1 期
A Single-arm, Open-label, Phase 1b Study Evaluating the Efficacy and Safety of Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI
Hanmi Pharmaceutical Company Limited8 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年3月29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
- 2
- 试验地点
- 8
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of olmutinib 600 mg QD in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).
详细描述
This is a single-arm, open-label, Phase 1b study to evaluate the efficacy and safety of oral single agent olmutinib administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent before any study-specific procedures (including special Screening tests) are performed.
- •At least 20 years of age at the time of signing informed consent.
- •Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy.
- •Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI with or without at least one line of chemotherapy.
- •At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q).
- •World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months.
- •Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen.
- •At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Females of child-bearing potential (not surgically sterilized and between menarche and one-year post-menopause) must agree to use adequate contraception (one of the following listed below) during the study (both men and women as appropriate) and for 3 months after the last dose of study drug.
- •Male patients should be documented to be sterile or agree to use barrier contraception i.e. condoms.
- •Recovery to ≤ Grade 1 or baseline of any toxicities due to prior treatments, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
排除标准
- •Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
- •Previous treatment with anticancer therapies, EGFR-TKI (including erlotinib, gefitinib, and afatinib) within 8 days or 5-fold half-life, whichever is the longer, of the first administration of study drug.
- •Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
- •Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
- •History of any other malignancy
- •Clinically significant uncontrolled condition(s)
- •Active or chronic pancreatitis
- •Anyone with cardiac abnormalities or history
- •Presence or history of interstitial lung disease (ILD), drug-induced ILD, or presence of radiation pneumonitis.
- •Pregnant or breast feeding.
- •In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713.
研究组 & 干预措施
Olmutinib 600mg
Experimental
HM61713 600 mg (1 x 400 mg + 1 x 200 mg tablets) once daily (QD)
干预措施: Olmutinib (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 24 months
Defined as a best overall confirmed response of either CR or PR according to the RECIST version 1.1
次要结局
- Time to progression (TTP)(24 months)
- Disease control rate (DCR)(24 months)
- Duration of overall tumor response (DR)(24 months)
- Progression-free survival (PFS)(24 months)
研究者
研究点 (8)
Loading locations...
相似试验
终止
2 期
A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic AlterationsSquamous Non-Small Cell Lung CancerMetastatic Lung CancerStage IV Lung CancerLung CancerNon-Small Cell Lung CancerSCLCNSCLCSmall Cell Lung CancerAdvanced Lung CancerNCT02109016Clovis Oncology, Inc.18
已完成
2 期
Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line TherapyNasopharyngeal CarcinomaNCT03906058Sun Yat-sen University39
终止
不适用
Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 PneumoniaCOVID-19PneumoniaNCT04331665University Health Network, Toronto3
Unknown
1 期
A Study of QL1706 Plus Lenvatinib in Subjects With Advanced Renal Cell Carcinoma(RCC)Advanced Renal Cell CarcinomaNCT05262413Qilu Pharmaceutical Co., Ltd.60
招募中
2 期
Obinutuzumab in Treatment of Fibrillary GlomerulonephritisFibrillary GlomerulonephritisNCT06295770Mayo Clinic20