EUCTR2015-001435-21-IT进行中（未招募）1 期
A single-arm, open-label, Phase 2 study evaluating the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) -
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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, locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy.
- •4. Radiologically confirmed disease progression following:
- •a. 1st line EGFR-TKI treatment without further anticancer treatment in the intervening period before the first administration of start drug OR
- •b. Prior therapy with a platinum-based doublet chemotherapy and with an EGFR-TKI in any sequence. Patients may have received additional
- •lines of anticancer treatment.
- •5. Documented EGFR mutations which are 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 and not chosen for biopsy during the study Screening period, that can be
- •accurately measured per 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 = 3 x ULN for patients who are known to have Gilbert's syndrome.
- •c. Creatinine = 1.5 x ULN.
- •d. Albumin = 2.5 g/dL.
- •e. Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 x ULN if no demonstrable liver metastases, or otherwise = 5 x ULN.
- •f. Amylase = 1.5 x ULN.
- •g. 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.
- •Patients who are not surgically sterilized must have a negative urine or serum pregnancy test ompleted during the Screening period. The following measures need to be followed for females of child-bearing potential:
- •a. Total abstinence from sexual intercourse as the preferred lifestyle of the patient.
- •b. Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
- •c. Intra-uterine device (IUD).
- •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 toxicity due to prior treatments, except for 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 60
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, andafatinib) within 10 days or 5-fold half-life, whichever is the longer, of the first administration of study drug.
- •c. Previous treatment with HM61713, or other drugs that target T790Mpositive mutant EGFR with sparing of wild-type EGFR (e.g. AZD9291, CO-
- •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. Current treatment with medications with known potential to prolong the QT interval which cannot be discontinued or switched to alternate medication prior to the first administration of study drug.
- •g. 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.
- •h. Current use of any drugs known as strong inducers or inhibitor of CYP2D6 or CYP3A4, unless the use is terminated before = 1 week of the
- •first administration of study drug.
- •3. Spinal cord compression, leptomeningeal carcinomatosis or other untreated or symptomatic brain metastases; patients with treated brain
- •metastases are eligible if stable for at least 4 weeks without the requirement for steroids or anti-epileptic therapy.
- •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. Pancreatitis within the past 6 months prior to the date of the first administration of study drug.Pancreatic assessment must be within
- •normal limits at Screening Visit.
- •7. Any of the following cardiac abnormalities or history:
- •a. Abnormal 12-lead ECG considered to be clinically significant by the investigator.
- •b. QT interval corrected using Fridericia's (QTcF) or Bazett's (QTcB) 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, experien
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