ACTRN12610000312044招募中3 期
A double blind placebo controlled randomized trial to evaluate the effect of PF-804 on overall survival in patients with incurable stage IIIb/IV non-small cell lung cancer after failure of standard therapy for advanced or metastatic disease
CIC Clinical Trials Group0 个研究点目标入组 720 人开始时间: 2010年4月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 720
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Histologically confirmed diagnosis of non-small cell carcinoma of the lung.
- •Patients must have evidence of disease, but measurable disease is not mandatory
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
- •Adequate renal and hepatic functions
- •Patients must have recovered from any toxic effects and at least 21 days must have elapsed from the
- •last dose and prior to randomization
- •Patients < 70 years Must have received 1-2 prior chemotherapy regimens
- •Patients > 70 years May have received 1 or 2 prior single agent chemotherapy regimens for their disease,
- •Adjuvant Chemotherapy: Patients may ALSO have had prior adjuvant therapy for completely
- •resected disease, providing completed at least 12 months prior to randomization.
- •Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy: Patients may only be enrolled after failure of prior gefitinib or erlotinib for advanced or metastatic disease
- •Radiation: Patients may have had prior radiation therapy provided that a minimum of 14 days has elapsed between the end of radiotherapy and randomization onto the study
- •Previous Surgery: Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed
- •Patient able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires.
- •Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements
- •Patients must be accessible for treatment and follow-up.
- •protocol treatment is to begin within 2 working days of patient randomization.
排除标准
- •Patients receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
- •Patients who have experienced untreated and/or uncontrolled cardiovascular conditions Patients with a significant cardiac history, even if controlled, should have a left ventricular ejection fraction (LVEF) > 50%.
- •Patients with untreated brain or meningeal metastases are not eligible (Computerised Tomography (CT) scans are not required to rule this out unless there is a clinical suspicion of Central Nervous System (CNS) disease).
- •Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which
- •would not permit the patient to be managed according to the protocol
- •Mean QTc (a measure of the time between the start of the Q wave and the end of the T wave) with Bazetts correction > 470msec in screening electrocardiogram (ECG) or history of familial long QT syndrome.
- •Drugs that are highly dependent on Cytochrome P450 2D6 (CYP2D6) for metabolism are prohibited
- •Pregnancy or inadequate contraception
研究者
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