DRKS00003301尚未招募2 期
A phase II trial to evaluate safety and efficacy of combined trastuzumab and AUY922 in advanced non-small cell lung cancer (NSCLC) with HER2 - overexpression or -amplification or - mutation. - TRY
niversität Köln0 个研究点目标入组 29 人开始时间: 2012年11月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Stage IV NSCLC patients after failure of at least one standard therapy with HER2 protein overexpression 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
- •following laboratory requirements conducted 14 days prior to treatment:
- •Hemoglobin = 9.0 g/dL
- •Absolute neutrophil count (ANC) = 1500 /mm3
- •Platelet count = 100,000/µL
- •Total bilirubin = 2 x ULN
- •ALT, AST and alkaline phosphatase (AP) = 2.5 x ULN or = 5.0 x ULN, if liver metastasis are present
- •PT-INR/PTT < 1.5 x ULN
- •Creatinine clearence (CrCl) = 60ml/min calculated by either MDRD-formel or by 24 hours urine collection
- •Total calcium (corrected for serum albumin) within normal limits or correctable with supplements
- •Magnesium within lower normal limits or correctable with supplements
- •Potassium within 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
- •-efective method of contraception (Pearl-Index not greater than 1%)
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 coumarin derivatives..Low doses of coumarin derivatives (e.g. < 2mg/day) are permitted
- •Pregnant or lactating women
- •Patients with concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes mellitus, active untreated of uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause) that could cause unacceptable safety risks or compromise compliance with the protocol
- •Impaired cardiac function including any of the following:
- •oHistory (or family history) of long QT syndrome
- •oMean QTcF = 450 msec on screening ECG
- •oHistory of clinically manifested ischemic heart disease = 6 months prior to study start
- •oHistory of heart failure or left ventricular (LV) dysfunction (LVEF = 45%) by transthoracal echocardiography
- •oClinically 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 block
- •oHistory or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes
- •oOther clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
- •oClinically significant resting bradycardia (< 50 beats per minute)
- •oPatients 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 AUY 922
- •oObligate use of a cardiac pacemarker
- •Known diagnosis of HIV, active hepatitis B and/or C (testing is not mandatory)
- •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 prior study start
- •Pregnancy, breast feeding
研究者
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