EUCTR2005-005484-28-SK进行中（未招募）1 期
A Multicenter, Open Label, Randomized Study of AMG 951 in Subjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without Bevacizumab
Amgen Inc.0 个研究点目标入组 224 人开始时间: 2008年4月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 224
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
- •Disease related
- •-Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC).
- •Mixed tumors will be categorized by the predominant cell type unless small cell
- •elements are present in which case the patient is ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy.
- •-Subjects must have advanced NSCLC defined as stage IIIb with malignant pleural effusion or Stage IV or recurrent disease. Subjects with non-measurable but evaluable disease can be included in the phase 1b study, but disease must be measurable to be included in the phase 2 study
- •-Planning to receive up to 6 cycles of chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (see
- •Appendix F)
- •Life expectancy greater than 3 months
- •Demographic:
- •=18 years old and of legal age for informed consent
- •Subjects must sign and date a written Independent Ethics Committee (IEC)-
- •approved Informed Consent Form
- •International Normalization Ratio (INR) = 1.2 and PTT = ULN within 1 week prior to enrollment
- •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
- •-Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ
- •cervical cancer), unless have been treated with curative intent with no evidence of disease for =3yrs
- •-Untreated or unstable central nervous system (CNS) metastases.
- •Subjects with CNS metastases that are both definitively treated and stably controlled are eligible for cohorts A and B of the phase 2 part of the study if all of the following apply: 1) definitive therapy has been administered (surgery and/or radiation therapy); 2) there is no planned treatment for brain metastases; 3) the subject is clinically stable; 4) the subject is off corticosteroids or on a stable dose of corticosteroids for at least 2 wks prior to enrollment
- •-Myocardial infarction, or unstable or uncontrolled disease or condition related to
- •or impacting cardiac function (e.g., unstable angina, congestive heart failure [New York Heart Association >class II]) within 1 yr of enrollment
- •-Uncontrolled hypertension defined as: systolic blood pressure =150 mm Hg OR
- •diastolic blood pressure =100mm Hg (antihypertensive therapy to achieve these
- •parameters is allowable)
- •-History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders within 1 yr of enrollment
- •-Recent major surgical procedure within 28 days of enrollment or not yet recovered from prior major surgery.
- •-Recent minor surgical procedure or core biopsy = 7 days prior to enrollment or not yet recovered from prior minor surgery. (Insertion vascular access device is not considered major or minor surgery).
- •-Subjects must not have serious non-healing wound ulcer, or bone fracture within
- •21 days prior to enrollment
- •-Persistent history of gross hemoptysis (defined as bright red blood of a ½teaspoon or more) relating to subject’s NSCLC
- •-Known (documented in medical notes) HIV infection
- •-Active infection on day of enrollment
- •-Known to be hepatitis C positive OR hepatitis B surface antigen positive
- •-Subjects with Gilbert’s syndrome
- •Within 7 days prior to enrollment the following test results must be obtained, unless otherwise specified:
- •-Absolute neutrophil count (ANC) <1.5 x 109 /L (without granulocyte-colony stimulating factor support within 2 wks of enrollment)
- •-Platelet count <100 x 109 /L (without transfusion within 2 wks of enrollment)
- •-Hemoglobin <9 g/dL (subjects may be transfused or receive erythropoietic treatment to meet criterion)
- •-Urine protein quantitative value of >1+ on dipstick or =30 mg/dL in urinalysis. If quantitative protein is <500 mg in 24hr urine collection then subject can be included
- •-Significant liver dysfunction as defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x upper limits of normal (ULN)
- •-Alkaline phosphatase >2.5 x ULN, or alkaline phosphatase >5 x ULN in the presence of bone or liver metastasis
- •-Total bilirubin >1.5 X ULN
- •-Calculated creatinine clearance <50mL/min.
- •-Hypercalcemia (serum calcium =12.0 mg/dL or symptomatic)
- •-Prior chemotherapy (except for adjuvant chemotherapy, provided the last dose of adjuvant therapy was received at least one year prior to enrollment), hormonal therapy, radiotherapy (except palliative radiotherapy for bone metastases or radiation therapy for CNS metastases) or immunotherapy for treatment of advanced NSCLC
- •-Prior drug treatment or therapy with investigational agents for advanced NSCLC
- •-Therapeutic anticoagulation treatment. Prophylactic anticoagulation of venous access devices (e.g., with low-dose warfarin
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