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临床试验/EUCTR2015-001435-21-DE
EUCTR2015-001435-21-DE进行中（未招募）1 期

A single-arm, open-label, Phase 2 study evaluating the efficacy, safety and pharmacokinetics of HM61713 (BI 1482694) in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI)

Hanmi Pharmaceutical Co., Ltd.0 个研究点目标入组 150 人开始时间: 2015年12月21日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
150
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Provide written informed consent before any study-specific procedures (including special Screening tests) are performed.
  • •2. At least 20 years of age at the time of signing informed consent.
  • •3. Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy.
  • •4. Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI with or without at least one line of chemotherapy.
  • •5. 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).
  • •6. World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months.
  • •7. Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen.
  • •8. At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • •9. Adequate hematological and biological function as follows:
  • •a. Absolute neutrophil count (ANC) = 1.5 x 109/L; hemoglobin = 9.0 g/dL; platelets = 100 x 109/L without the use of hematopoietic growth factors.
  • •b. Total bilirubin = 1.5 times the upper limit of normal (ULN), or = 4 x ULN for patients who are known to have Gilbert’s syndrome.
  • •c. Creatinine = 1.5 x ULN.
  • •d. Aspartate transaminase (AST) and ALT = 3 x ULN if no demonstrable liver metastases, or otherwise = 5 x ULN.
  • •e. Potassium and magnesium = 1.0 x ULN (supplementation is permissible).
  • •10. 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. Subjects who are not surgically sterilized must have a negative urine or serum pregnancy test completed during the Screening period. The following measures need to be followed for females of child-bearing potential:
  • •a. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
  • •b. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
  • •c. Intrauterine device (IUD).
  • •d. Intrauterine hormone-releasing system (IUS).
  • •e. Bilateral tubal occlusion.
  • •f. Vasectomised partner.
  • •g. Sexual abstinence.
  • •11. Male patients should be documented to be sterile or agree to use barrier contraception i.e. condoms.
  • •12. Recovery to = Grade 1 or baseline of any toxicities due to prior treatments, except for stable sensory neuropathy
  • •= Grade 2 and alopecia.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 100
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 50

排除标准

  • •1. Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713.
  • •2. Treatment with any of the following:
  • •a. Anticancer therapies including chemotherapy, hormonal treatment, or immunotherapy within 14 days of the first administration of study drug.
  • •b. Treatment with an 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.
  • •c. Previous treatment with the combination of afatinib+cetuximab HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type EGFR (e.g. AZD9291, CO-1686).
  • •d. Treatment with any investigational agent(s) within 28 days prior to the first administration of study drug.
  • •e. Radiotherapy with wide-field or more than 30% of the bone marrow within the past 2 weeks prior to the first administration of study drug; localized palliative radiation (e.g. localized skeletal metastasis) is permitted.
  • •f. Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug, except those related to this study.
  • •3. Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases except for the followings:
  • •a. Asymptomatic brain metastases incidentally found during screening process which do not require corticosteroids and/or local treatment in the opinion of the investigator.
  • •b. Asymptomatic brain metastases for which local treatment has been given; at least 1 week off corticosteroids and/or anticonvulsants treatment before study randomization.
  • •4. History of any other malignancy (other than curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors Ta [non-invasive tumor] and TIS [carcinoma in situ]) unless it has been definitively treated with no ongoing therapy or evidence of relapse or recurrence within the past 3 years.
  • •5. Clinically significant uncontrolled condition(s), including but not limited to:
  • •a. Refractory nausea and vomiting, inability to swallow the formulated product, or any gastrointestinal disorder, which may interfere with the administration or metabolism of the study drug.
  • •b. Active infection that requires parenteral antibiotics.
  • •c. Known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C.
  • •d. Psychiatric illness/social situations that would limit compliance with study requirements.
  • •e. Known or suspected substance abuse or alcohol abuse.
  • •f. Any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.
  • •6. Active or chronic pancreatitis assessed by the investigator
  • •7. Any of the following cardiac abnormalities or history:
  • •a. Abnormal 12-lead ECG considered to be clinically significant by the investigator.
  • •b. Mean QT interval corrected using Fridericia’s (QTcF) method > 450 msec.
  • •c. Personal or family history of long QT syndrome, second or third degree heart block.
  • •d. Implanted pacemaker or cardioverter defibrillator.
  • •e. Resting bradycardia < 55 beats/min.
  • •f. Uncontrolled hypertension.
  • •g. New York Heart Association (NYHA) class III or IV cardiac insufficiency, experienced unstable angina pectoris or cardiac infarction within 6 months, uncontrolled cardiac arrhythmia.
  • •h. Left ventricular ejection fraction (LVEF) < 40%.
  • •8. Presence or history of interstitial lung disease (ILD), drug-induced ILD, or presence of r

研究者

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