EUCTR2006-000259-16-DE进行中（未招募）1 期
A Phase III, Randomised, Double-Blind, Multi-Centre Parallel-Group Study to Assess the Efficacy of ZD6474 (ZACTIMA™ ) Versus Erlotinib (TARCEVA®) in Patients With Locally Advanced or Metastatic (Stage IIIB – IV) Non-Small Cell Lung Cancer (NSCLC) after Failure of at least One Prior Cytotoxic Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,150
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.Provision of informed consent
- •2.Female or male aged 18 years and over
- •3.Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIB-IV). Sputum cytology alone is not acceptable. Cytology specimens obtained by brushing, washing, or needle aspiration are acceptable.
- •4.Failure of at least one, but no more than two, prior cytotoxic chemotherapy regimens (either radiological documentation of disease progression or due to toxicity).
- •5.WHO Performance status 0 – 2
- •6.One or more measurable lesions at least 10 mm in the longest diameter (LD) by spiral CT scan or 20 mm with conventional techniques according to RECIST criteria
- •7.Negative pregnancy test for women of childbearing potential
- •8.Life expectancy of 12 weeks or longer.
- •9.Able to read and write
- •For inclusion in the genetic research part of the study, patients must fulfil the following criterion:
- •10.Provision of informed consent for genetic research and tissue sampling
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Mixed small cell and non small-cell lung cancer histology
- •2.Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab [Erbitux] or bevacizumab [Avastin] is permitted)
- •3.Chemotherapy or other systemic anti-cancer therapy within 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
- •4.Radiation therapy within 4 weeks before the start of study therapy, not including local palliative radiation. Lesions that have received radiation in the advanced setting cannot be included as target lesions unless clear tumour progression has been documented in the lesions since the end of radiation therapy
- •5.Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy
- •6.Any unresolved toxicity > CTCAE grade 2 from previous anti-cancer therapy
- •7.Serum bilirubin greater than 1.5x upper limit of reference range (ULRR)
- •8.Serum creatinine clearance =30 ml/min (calculated by Cockcroft-Gault formula) See Appendix G of protocol.
- •9.ALT or AST > 2.5 x ULRR if no demonstrable liver metastases, or > 5 x ULRR if judged by the Investigator to be related to liver metastases
- •10.Alkaline phosphatase (ALP) > 2.5 x ULRR if no demonstrable liver metastases, or > 5 x ULRR if judged by the Investigator to be related to liver metastases
- •11.Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease (see appendix I of protocol) =2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia
- •12.History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation), which is symptomatic or requires treatment (CTCAE grade 3 or 4) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication, is not excluded.
- •13.Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
- •14.QT prolongation with other medications that required discontinuation of that medication
- •15.Presence of left bundle branch block (LBBB)
- •16.QTc with Bazett’s correction unmeasurable or = 480 msec or greater on screening ECG. (Note: If a patient has QTc =480 msec on screening ECG, the screen ECG may be repeated twice [at least 24 hours apart]. The average QTc from the three screening ECGs must be <480 msec in order for the patient to be eligible for the study). Patients who are receiving a drug that has a risk of QTc prolongation (see Appendix D, Table 2) are excluded if QTc is = 460 msec.
- •17.Potassium <4.0 mmol/L despite supplementation; serum calcium (or ionized or adjusted for albumin), or magnesium out of normal range despite supplementation
- •18.Women who are pregnant or breast feeding
- •19.Concomitant medications that may cause QTc prolongation or induce Torsades de Pointes (see appendix D of protocol). Drugs listed in Appendix D, Table 2, that in the Investigator’s opinion cannot be discontinued, are allowed.
- •20.Concomitant medications that are potent inhibitors (ketoconazole, itraconazole, atanazavir, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO) and voriconazole) or inducers (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital and St. John's Wort) of CYP3A4 function
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