EUCTR2005-004749-32-AT进行中（未招募）不适用
A Phase III, Randomized, Double-Blinded, Multi-Centre Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination with ZD6474 (ZACTIMA™) versus Docetaxel (TAXOTERE™) in combination with Placebo in Patients With Locally Advanced or Metastatic (Stage IIIb – IV) Non-small Cell Lung Cancer (NSCLC) after Failure of 1st Line Anti-Cancer Therapy
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,240
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
- •4. Failure of 1 st line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) or subsequent relapse of disease following first line therapy
- •5. WHO PS 0 – 1
- •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
- •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. Patients who have received second-line anti-cancer therapy
- •3. Prior treatment with docetaxel (prior treatment with paclitaxel is acceptable)
- •4. Prior treatment with VEGFR TKIs (previous treatment with bevacizumab [Avastin] is permitted)
- •5. The last dose of prior chemotherapy or other anti-cancer therapy is discontinued less than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin, and suramin)
- •6. The last radiation therapy within 4 weeks before the start of study therapy, not including local palliative radiation
- •7. Major surgery within 4 weeks, or incompletely healed surgical incision
- •8. Any unresolved toxicity > CTCAE grade 2 from previous anti-cancer therapy
- •9. Neutrophils <1.5 x 10e9 /L or platelets <100 x 10 e9 /L
- •10. Serum bilirubin greater than upper limit of reference range (ULRR)
- •11. Serum creatinine >1.5 x ULRR or creatinine clearance
- •12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 x ULRR or alkaline phosphatase >2.5 x ULRR
- •13. Significant cardiovascular event (eg. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease 2 [See Appendix L]) within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia
- •14. 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.
- •15. Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
- •16. QT prolongation with other medications that required discontinuation of that medication
- •17. Presence of left bundle branch block (LBBB)
- •18. QTc with Bazett’s correction unmeasurable or =480 msec on screening ECG (Note: If a patient has QTc interval > or = 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.)
- •19. Potassium <4.0 mmol despite supplementation; serum calcium (ionized or adjusted for albumin), or magnesium out of normal range despite supplementation
- •20. Women who are pregnant or breast feeding
- •21. Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes (see Appendix F of the protocol for the lists of medications in Table 1 & Table 2) or induce CYP3A4 function (see Section 3.7.2)
- •22. Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable without steroid treatment for 10 days
- •23. Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 millimeter of mercury [mmHg] or diastolic blood pressure greater than 100 mmHg)
- •24. Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell or squamous cell carcinoma of the skin
- •25. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator’s opinion makes it
研究者
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