EUCTR2011-005655-13-DE进行中（未招募）1 期
A phase II trial to evaluate safety and efficacy of combined trastuzumab and AUY922in advanced non-small cell lung cancer (NSCLC) with HER2 - overexpression or -amplification or - mutation. - TRY
niversity of Cologne0 个研究点目标入组 29 人开始时间: 2012年5月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 29
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
- •Stage IV NSCLC patients after failure of at least one standard therapy with HER2 protein overexpression (HER2 score 3+) or gene amplification (FISH
- •positive) or mutation
- •Age > 18 years
- •ECOG performance status 0 to 2
- •Life expectancy of at least 12 weeks
- •Evaluable disease or disease measurable per Response Evaluation Criteria in
- •Solid Tumors (RECIST)
- •Adequate bone marrow, liver and renal function and adequate electrolyte
- •balance as assessed by the following laboratory requirements conducted at least
- •14 days prior to treatment:
- •o Hemoglobin = 8.5 g/dL
- •o Absolute neutrophil count (ANC) = 1000 / µl
- •o Platelet count = 80,000/µL
- •o Total bilirubin = 2 x ULN
- •o ALT, AST and alkaline phosphatase (AP) = 2.5 x ULN
- •o PT-INR/PTT < 1.5 x ULN
- •o Creatinine clearence (CrCl) = 60ml/min calculated by either MDRD-formel or
- •by 24 hours urine collection
- •o Total calcium (corrected for serum albumin) within normal limits or
- •correctable with supplements.
- •o Magnesium within lower normal limits or correctable with
- •supplements
- •Written informed consent (after adequate explanation of the trial) to participate
- •in the trial and to adhere to trial procedures, as well as consenting to data
- •protection procedures
- •In case of females with childbearing potential (definition of menopause is no
- •bleeding at least 12 months after last menstruation):
- •- negative serum pregnancy test in women with childbearing potential
- •- effective method of contraception (Pearl-Index not greater than 1%)
- •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 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Known hypersensitivity to any study medication
- •Other history of ongoing malignancy that would potentially interfere with the
- •interpretation of efficacy
- •Previous treatment with Hsp90 inhibitors (e.g.17-AAG)
- •Treatment with therapeutic doses of sodium warfarin (coumadin). Low doses
- •of coumadin (e.g. < 2mg/day) are permitted
- •Patients with concurrent severe and/or uncontrolled medical conditions (e.g.
- •uncontrolled diabetes mellitus, active untreated or uncontrolled infection,
- •chronic obstructive or chronic restrictive pulmonary disease including
- •dyspnea at rest from any cause or requiring supplementary oxygen therapy)
- •that could cause unacceptable safety risks or compromise compliance with
- •the protocol
- •Impaired cardiac function including any of the following:
- •o History (or family history) of long QT syndrome
- •o Mean QTc = 450 msec on screening ECG
- •o History of clinically manifest ischemic heart disease = 6 months prior
- •to start of the study
- •o History of heart failure or left ventricular (LV) dysfunction (LVEF =
- •45%) by transthoracic echocardiography
- •o Clinically significant ECG abnormalities including one or more of
- •the following: left bundle brunch block (LBBB), right bundle brunch
- •block (RBBB) with left anterior hemiblock (LAHB), ST segment
- •elevations or depressions > 1 mm or 2nd (Mobitz II) or 3rd degree AV
- •o History or presence of atrial fibrillation, atrial flutter or ventricular
- •arrhythmias including ventricular tachycardia or torsades de pointes
- •o Other clinically significant heart disease (e.g. congestive heart
- •failure, uncontrolled hypertension or history of unstable
- •hypertension)
- •o Clinically significant resting bradycardia (< 50 beats per minute)
- •o Patients who are currently receiving treatment with any medication
- •which has a relative risk of prolonging the QTc interval or inducing
- •torsades de pointes and cannot be switched or discontinued to an
- •alternative drug prior to commencing AUY922
- •o Obligate use of a cardiac pacemarker
- •o Angina pectoris requiring a medicinal producto Evidence of transmural infarction on ECG
- •o Clinically significant valvular disease
- •Known diagnosis of HIV, active hepatitis B and/or C (testing is not
- •Clinically symptomatic leptomeningeal or brain metastases (patients with
- •clinically stable brain metastases may be enrolled)
- •Any person being in an institution on assignment of the respective authority
- •Any medical, mental or psychological condition which in the opinion of the
- •investigator would not permit the patient to complete the study or understand
- •the patient information
- •Any serious medical condition with organ impairment
- •Parallel participation in another clinical trial
- •Experimental or other therapy within the last 30 days or 5 half-life's,
- •whatever is of longer duration (with exception of trastuzumab, if patient is
- •recruited directly for combination treatment)
- •Pregnancy, breast feeding
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