PER-108-06已完成未知
A Phase III Study to Assess the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care Versus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer After Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)
ASTRAZENECA - PERU,0 个研究点目标入组 0 人开始时间: 2007年1月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 0（—）
- 性别
- All
入选标准
- •1. Granting of informed consent.
- •2. Male or female from 18 years of age.
- •3. Histological or cytological confirmation of locally advanced or metastatic NSCLC upon entering the study.
- •4. Failure of previous treatment with an EGFR TKI.
- •5. WHO functional status 0-2.
- •6. Measurable disease according to RECIST.
- •7. Negative pregnancy test in women with reproductive potential.
- •8. Life expectancy of 12 weeks or more.
排除标准
- •1. Histology of small cell and non-small cell mixed lung cancer
- •2. Pre-treatment with VEGFR TKIs.
- •3. Chemotherapy or other treatment for systemic cancer within 4 weeks before the start of study medication.
- •4. Three or more previous chemotherapy regimens for advanced disease.
- •5. Last radiotherapy within 4 weeks before the start of the study medication.
- •6. Major surgery within the previous 4 weeks or surgical incision not completely healed before starting the study treatment.
- •7. Any toxicity grade CTCAE> 2 of previous treatment for cancer
- •8. Serum bilirubin> 1.5 x LSRR
- •9. Serum creatinine> 1.5 LSRR or creatinine clearance ≤ 50 ml / min.
- •10. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 2.5 x LSRR in the absence of liver metastases, or> 5 LSRR in the presence of liver metastases.
- •11. Alkaline phosphatase (FAL)> 2.5 x LSRR in the absence of liver metastases, or> 5 X LSRR in the presence of liver metastases.
- •12. Significant cardiovascular event, Classification of the New York Heart Association ≥ 2 within 3 months prior to admission.
- •13. History of arrhythmia that is symptomatic and requires treatment or sustained asymptomatic ventricular tachycardia.
- •14. Congenital or prolonged QT syndrome, 1st degree relative with sudden death of unknown cause before 40 years of age.
- •15. Prolongation of the QT by another medication, requiring the continuation of it.
- •16. Presence of left branch block.
- •17. QTc with Bazzet correction not measurable or> 480 msec or greater in the ECG of the selection.
- •18. Potassium <4.0 mmol / l despite supplementation; serum calcium, or magnesium outside the normal range despite supplementation.
- •19. Pregnant or breastfeeding women.
- •20. Any concomitant medication that may cause QTc prolongation or induce Torsades de Pointes or induce the function of CYP3A4.
- •21. Known or suspected brain metastases or spinal cord compression, unless treated 4 weeks prior to admission, and stable without steroid treatment for 10 days
- •22. Uncontrolled hypertension with medical treatment.
- •23. Previous or current malignancies of other histologies within the previous 5 years.
- •24. Evidence of severe or poorly controlled systemic disease or any concurrent condition, which in the opinion of the investigator makes the patient´s participation in the study inappropriate or that could risk compliance with the protocol.
- •25. Enrollment or randomization prior to treatment in the present study.
- •26. Commitment to conduct the study
- •27. Participation in a clinical study of any experimental agent within 30 days prior to the start of study treatment.
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