EUCTR2007-000819-29-IT进行中（未招募）不适用
A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated with Second-Line Docetaxel after Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) - VITA
sanofi-aventis recherche & de'veloppement0 个研究点目标入组 910 人开始时间: 2007年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 910
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
- •Histological/cytological proven locally advanced or metastatic non-small cell lung cancer. - Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based (chemotherapy or targeted therapy) for advanced or metastatic disease. Disease progression within 6 months of adjuvant platinum-based chemotherapy is accepted
- •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
- •Related to the methodology Squamous histology/cytology <28 days elapsed from prior radiotherapy, surgery, or chemotherapy to the time of randomization. <42 days elapsed from prior major surgery (lung resection) to the time of randomization. Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 25% of bone marrow Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1 NCI CTCAE v.3.0) at the time of randomization. Age <18 years. Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 2. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. History of another neoplasm. Adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for > 5 years are allowed. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. Any of the following events within the 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, grade 3 or 4 gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event. Any of the following events within the 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft surgery, NYHA III or IV CHF, stroke or TIA Occurrence of deep vein thrombosis within 4 weeks, prior to randomization. Acquired immunodeficiency syndrome (AIDS-related illnesses)or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment Any severe acute or chronic medical condition, which could impair the ability of the patient to participate to the study or interfere with interpretation of study results. Absence of signed and dated Institutional Review Board (IRB)- approved patient informed consent form prior to enrollment into the study. Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization. Patient with reproductive potential (M/F) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. - Related to aflibercept History of prior discontinuation of any anti-VEGF agent due to adverse drug reaction. Urine protein:creatinine ratio (UPCR) > 1 on morning spot urinalysis or proteinuria > 500 mg/24h. Serum Creatinine > 1.5 x ULN Uncontrolled hypertension, defined as blood pressure >150/100 mm Hg (grade ≥ 2 according to NCI CTCAE v.3.0), or systolic blood pressure >180 mm Hg if diastolic blood pressure <90 mm Hg, on at least 2 repeated determinations on separate days, within 3 months prior to study randomization. Patients on anticoagulant therapy with unstable dose of warfarin and/or having an out-of-therapeutic range INR (>3) within 4 weeks prior to randomization. Evidence of clinically significant bleeding diathesis including hemoptysis, or underlying coagulopathy , non-healing wound. - Related to docetaxel Prior docetaxel treatment. Pts refractory to first line paclitaxel-based therapy History of hypersensitivity to docetaxel, or polysorbate 80. − Hemoglobin < 1
研究者
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