A Phase III, International, Randomised, Double-Blind, Parallel-Group, Multi-Centre Study to Assess the Efficacy of ZD6474(ZACTIMA™) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB – IV) Non-Small Cell Lung Cancer (NSCLC) after Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)

AstraZeneca AB0 个研究点目标入组 930 人开始时间: 2006年9月27日最近更新: 2015年2月16日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: AstraZeneca AB
入组人数: 930

研究概览入排标准研究者记录与标识符相似试验

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) on entry into study. (Sputum cytology alone is not acceptable. Cytology specimens obtained by brushing, washing or needle aspiration are acceptable.)
•4.Failure of prior therapy (during or after treatment) with an EGFR TKI (either radiological documentation of disease progression or due to toxicity) in patients who have received at least one but no more than two prior chemotherapy regimens.
•5.WHO Performance status 0 – 2
•6.Measurable disease defined as - 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
•7.Negative pregnancy test for women of childbearing potential
•8.Life expectancy of 12 weeks or longer
•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 VEGFR TKIs (prior treatment with bevacizumab [Avastin] is permitted)
•3.Chemotherapy or other systemic anti-cancer therapy within 4 weeks (3 weeks for EGFR TKIs) before the start of study therapy (6 weeks for nitrosoureas,
•mitomycin and suramin).
•4.Three or more prior chemotherapy regimens for advanced disease (one additional regimen allowed for neoadjuvant or adjuvant therapy). Note; chemotherapy or other anti-cancer agents are not allowed during treatment with ZD6474 / Placebo.
•5.The last radiation therapy within 4 weeks before the start of study therapy, not including local palliative radiation.
•6.Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy
•7.Any unresolved toxicity > CTCAE grade 2 from previous anti-cancer therapy
•8.Serum bilirubin >1.5 x ULRR
•9.Creatinine Clearance < 30ml/min (calculated by Cockcroft-Gault formula [see appendix G])
•10.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x ULRR in the absence of liver metastases, or >5 x ULRR in the presence of liver metastases
•11.Alkaline phosphatase (ALP) >2.5 x ULRR in the absence of liver metastases, or >5 x ULRR in the presence of liver metastases
•12.Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome), New York Heart Association [NYHA] classification of heart
•disease =2 [See Appendix H]) within 3 months before starting study therapy, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia
•13.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 asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
•14.Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
•15.QT prolongation with other medication that required discontinuation of that medication
•16.Presence of left bundle branch block (LBBB)
•17.QTc with Bazett’s correction unmeasurable or =480 msec or greater on screening ECG (Note: If a patient has a QTc interval =480 msec on screening ECG, the screening ECG may be repeated twice [at least 24 hrs 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.
•18.Potassium <4.0 mmol/L despite supplementation; serum calcium (or ionized or adjusted for albumin), or magnesium out of normal range despite supplementation
•19.Women who are pregnant or breast feeding
•20.Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes (see Appendix D for the lists of medications in Table 1 & Table 2) or induce CYP3A4 function (see Section 3.6.2) within 2 weeks of start of study
•therapy. Drugs listed in Appendix D, Table 2, that in the investigator’s opinion cannot be discontinued, are allowed, provided the precautions outlined in section 3.2.2.1 are adhered to.
•21.Known or suspected brain metastases or spinal cord compression, unless treated at least 4 weeks before starting study therapy, and stable without steroid

研究者

发起方

AstraZeneca AB

相似试验

进行中（未招募）

不适用

A Phase III, International, Randomised, Double-Blind, Parallel-Group, Multi-Centre Study to Assess the Efficacy of ZD6474(ZACTIMA™) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB – IV) Non-Small Cell Lung Cancer (NSCLC) after Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)

EUCTR2006-002384-12-BEAstraZeneca AB930

进行中（未招募）

1 期

EUCTR2006-002384-12-GBAstraZeneca AB1,140

进行中（未招募）

不适用

EUCTR2006-002384-12-FRAstraZeneca AB941

进行中（未招募）

不适用

EUCTR2006-002384-12-NLAstraZeneca AB930

进行中（未招募）

不适用

EUCTR2006-002384-12-ATAstraZeneca930