NCT02444819已完成2 期
A Multicenter, Single-arm, Phase II Exploratory Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line Anticancer Agent in NSCLC Patients With EGFR Mutation
Hanmi Pharmaceutical Company Limited0 个研究点目标入组 33 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- Objective response rate
研究概览
简要总结
A multi-center, single-arm. Phase 2 exploratory trial to evaluate the efficacy and safety of HM61713 as the 1st-line anticancer agent in none-small cell lung cancer patients with EGFR mutation
详细描述
HM-EMSI-201 study targets NSCLC patients with EGFR mutations by HM61713 anticancer drug as the first-line 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 19 years at the time of signing informed consent
- •Cytologically or histologically confirmed, advanced or metastatic NSCLC which is not amenable to curative surgery (Stage IIIb or IV)
- •Documented EGFR mutations (excluding exon 20 insertion)
- •At least one lesion that can be used as a measurable lesion per RECIST version 1.1
- •Performance status under 1 per ECOG score
- •Life expectancy of at least 12 weeks
- •Adequate hematological and biological functions
- •Provide voluntary consent to participate the study and sign the written consent form
排除标准
- •Treatment of chemotherapy, biological therapy or immunotherapy for anticancer therapies of stage IIIb or IV NSCLC (excluding adjuvant/neoadjuvant chemotherapy, radiotherapy or radiochemotherapy prior to more than 6 months from the first dose of study treatment
- •History of treatment with an EGFR targeting small molecule or antibodies
- •Any non-study related significant surgical procedures requires general anesthesia or breathing apparatus within the past 4 weeks of the first dose of study treatment (excluding video-assisted thoracoscopic surgery or open-and-closed surgery prior to the past 2 weeks of the first dose of study treatment)
- •History of any other malignancy within 5 years of study participation (other than curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors unless it has been definitively treated with no evidence of relapse or recurrence within the past 3 years)
- •Clinically significant uncontrolled conditions of infectious disease including active infection that requires parenteral antibiotics (except when conditions are definitively treated or controlled)
- •Spinal cord compression, leptomeningeal carcinomatosis, symptomatic or uncontrolled brain metastasis
- •Presence or history of ILD or pulmonary fibrosis
- •NYHA class III or IV cardiac insufficiency, uncontrolled hypertension, experienced unstable angina pectoris or cardiac infarction within 6 months, uncontrolled cardiac arrhythmia or clinically significant abnormal cardiovascular activities
- •LVEF < 40%
- •Presence or history of pancreatitis or serum amylase > 1.5xULN
- •Inability to swallow the formulated product or gastrointestinal tract abnormalities which would preclude administration or absorption of study medication
- •Mental or congenital disabilities (e.g. dementia or epilepsy) which would preclude understanding of informed consent or following the study protocol
- •History of hypersensitivities to investigational drug or related similar class drugs
- •Pregnant or breast feeding
- •Unwillingness of adequate contraception during study treatment and at least 2 months after treatment
- •Unwillingness of following procedures of study protocol or follow-up assessments; Unable to follow up for long term for psychological, social, family problem or geographical reasons
- •History of treatment with other investigational drugs or investigational medical devices prior to 28 days of the first dose of study treatment
- •In the opinion of the investigator, the patient is an unsuitable candidate to the study
- •ECG finding of QTcF > 450 msec at rest
研究组 & 干预措施
HM61713
Experimental
Subjects who entered the study will be administered HM61713 800 mg per day.
干预措施: HM61713 (Drug)
结局指标
主要结局
Objective response rate
时间窗: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1
次要结局
- Progression-free survival(At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year)
- Time to progression(At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year)
- Quality of life questionnaire(At baseline and every visit, expected average 1 year)
- Disease control rate(At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year)
- overall survival(At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year)
- Maximum decrease in tumor size(At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year)
研究者
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