EUCTR2005-005484-28-GB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: 2006年3月24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
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, 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 additional treatment planned 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 2wks 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) within 1yr of enrollment
- •-Uncontrolled hypertension defined as: systolic blood pressure =150mm 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 1yr of enrollment
- •-Recent major surgical procedure within 28dys prior to 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
- •21dys prior to enrollment
- •-Persistent history of gross hemoptysis (defined as bright red blood of a ½tspn or more) relating to subject’s NSCLC
- •-Known (documented in medical notes) HIV infection
- •-Active infection on day of enrollment
- •-Known to be hep C positive OR hep 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) <1.5x109/L (without granulocyte-colony stimulating factor support within 2wks of enrollment)
- •-Platelet count <100x109 L (without transfusion within 2wks of enrollment)
- •-Hemoglobin <9g/dL (subjects may be transfused or receive erythropoietic treatment to meet criterion)
- •-Urine protein quantitative value of >1+ on dipstick or >30mg/dL in urinalysis. If
- •quantitative protein is <500mg in 24hr urine collection then subject can be included
- •-Significant liver dysfunction as defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>2.5xupper limits of normal (ULN)
- •-Alkaline phosphatase >2.5xULN, or alkaline phosphatase >5xULN in the presence of bone or liver metastasis
- •-Total bilirubin >1.5XULN
- •-Calculated creatinine clearance <50mL/min.
- •-Hypercalcemia (serum calcium =12.0mg/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, ra
研究者
相似试验
进行中（未招募）
不适用
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 - 20050190Treatment of patients with stage IIIb/IV non-small cell lung cancerMedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2005-005484-28-ITAmgen Inc.224
已完成
2 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 BevacizumablungcancerNon Small Cell Lungcancer10029107NL-OMON31650Amgen19
进行中（未招募）
不适用
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 BevacizumabSubjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without BevacizumabMedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IVMedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIBEUCTR2005-005484-28-PLAmgen Inc.200
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 BevacizumabSubjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without BevacizumabMedDRA version: 8.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIBMedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IVEUCTR2005-005484-28-SKAmgen Inc.224
进行中（未招募）
不适用
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 BevacizumabSubjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without BevacizumabMedDRA version: 8.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIBMedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IVEUCTR2005-005484-28-BEAmgen Inc.224