EUCTR2018-000399-13-DE进行中（未招募）1 期
A phase II trial to evaluate efficacy and safety of erdafitinib in patients with advanced NSCLC harbouring FGFR genetic alterations after relapse of standard therapy - FIND
niversity of Cologne0 个研究点目标入组 50 人开始时间: 2018年10月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Age > 18 years
- •Stage IIIB/IV NSCLC patients with activating FGFR alteration after failure on standard treatment, or in the opinion of the investigator no effective standard therapy exists, is appropriate, tolerated, or is considered equivalent to study treatment
- •Activating FGFR alteration as approved by FIND Molecular Board
- •ECOG performance status score 0, 1, or 2.
- •Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •Clinical laboratory values and cardiovascular measurements at screening:
- •Hemoglobin?8 g/dL (?5 mmol/L) (must be without red blood cell [RBC] transfusion within 7 days prior to the laboratory test; recombinant human erythropoietin use is permitted)
- •Platelets?75×109/L
- •Absolute Neutrophil Count (ANC)?1.5×109/L (prior growth factor support is permitted more than 7 days prior to the laboratory test)
- •AST and ALT=2.5 × upper limit of normal (ULN) or
- •=5 × ULN for patients with liver metastases
- •Creatinine clearance?40 mL/min based upon CKD-EPI formula
- •Total bilirubin=1.5 × ULN; except in patients with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin =1.5 × ULN is required)
- •Cardiovascular
- •Corrected QT interval according to Fridericia (QTcF)=480 msec based on the average of triplicate assessments performed approximately 5 minutes apart
- •ALT=alanine aminotransferase; ANC=absolute neutrophil count; AST=aspartate aminotransferase; GFR=glomerular filtration rate; QTcF=QT corrected interval by the Fridericia’s formula; ULN=upper limit of normal
- •Disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for cohort 1 and 2.
- •A woman of childbearing potential (WOCBP) who is sexually active must have a negative pregnancy test (beta- human chorionic gonadotropin [beta-hCG]) at Screening (urine or serum, minimum sensitivity 25 IU/L or equivalent units of beta-HCG) within 24 hours prior to the start of erdafitinib.
- •WOCBP and men who are sexually active with WOCBP must use appropriate method(s) of contraception with a failure rate of less than 1% per year before study entry, during the study and until 5 months after taking the last dose of study drug.
- •Note: Appropriate methods of contraception are:
- •Total abstinence, if it is the appropriate lifestyle, female sterilization or tubal ligation (at least 6 weeks prior to the start of the study treatment), male sterilization (at least 6 months prior to the start of the study treatment) and/or a combination of a hormonal method of contraception with a barrier method or/and an intrauterine device or system are considered as highly effective methods of contraception.
- •Sexually active men must use a condom to prevent delivery of the drug via seminal fluid
- •Women must not be breastfeeding.
- •Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
- •Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, during the study and for 5 months after the last dose of study drug
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects
排除标准
- •Pathogenic somatic alterations in the following genes: EGFR, BRAF, ALK ROS1 and NTRK (Please note that molecular testing might be reduced in heavy smokers with NSCLC. If discrepancies occur, please contact the sponsor). •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 30 days or 5 half-life times (whichever is longer) prior to recruitment.
- •Treatment with small molecules or chemotherapy within 7 days prior to C1D1
- •Treatment with monoclonal antibodies within 28 days prior to C1D1.
- •Any other ongoing malignancy that would potentially interfere with the interpretation of erdafitinib efficacy.
- •Symptomatic central nervous system metastases.
- •Received prior FGFR inhibitor treatment or if the patient has known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
- •Any corneal or retinal abnormality likely to increase the risk of eye toxicity, i.e.:
- •a.History of or current evidence of central serous retinopathy (CeSR) or retinal vascular occlusion (RVO)
- •b.Active wet, age-related macular degeneration (AMD)
- •c.Diabetic retinopathy with macular edema (non-proliferative)
- •d.Uncontrolled glaucoma (per local standard of care)
- •e.Corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration.
- •Has persistent phosphate level >ULN during screening (on 2 consecutive assessments at least 1 week apart, within 14 days prior to Cycle 1 Day 1) and despite medical management
- •Has a history of current uncontrolled cardiovascular disease including:
- •a.unstable angina, myocardial infarction, ventricular fibrillation, Torsades de Pointes tachycardia, cardiac arrest, or known congestive heart failure NYHA Class III-V within the preceding 3 months (Appendix 3); cerebrovascular accident or transient ischemic attack within the preceding 3 months.
- •b.QTcF prolongation as confirmed by triplicate assessment at screening (QTcF >480 milliseconds).
- •Pulmonary embolism or other VTE (venous thromboembolism) within the preceding 2 months
- •Known human immunodeficiency virus (HIV) infection, testing is mandatory (a-HIV 1/2)
- •Patients with acute or chronic Hepatitis B infection (tests should include assessment of HBsAg and HBc IgG antibody. If one parameter is positive, determine HBV-DNA to confirm acute infection. Patients with positive results for HBsAg and/or HBV-DNA are considered positive for acute or chronic infection)
- •Patients with acute or chronic Hepatitis C infection (determine HCV-RNA. Patients with positive result for HCV-RNA are considered positive for acute or chronic infection)
- •Has not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, Grade 1 neuropathy, Grade 1-2 hearing loss)
- •Has impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
- •Major surgery within 2 weeks of the first dose, or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 2 weeks after the last dose of study drug administration. (Note: patients with planned surgical procedures to be conducted under local anesthesia may participate).
- •Any serious underlying medical condition, such as:
- •a. Evidence of serious active viral, bacterial, or uncontrolled syste
研究者
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