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 - 20050190

Amgen Inc.0 个研究点目标入组 224 人开始时间: 2008年11月11日最近更新: 2013年1月7日

适应症

试验速览

暂无简介。

•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 • ECOG performance status of 0 or 1 • Life expectancy greater than 3 months • `?¥ 18 years old • 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: 0
•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

•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 `?¥ 3 years • 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 2 weeks prior to enrollment • Myocardial infarction, or unstable or uncontrolled disease or condition related to or impacting cardiac function (eg, unstable angina, congestive heart failure [New York Heart Association > class II]) within 1 year of enrollment • Uncontrolled hypertension defined as: systolic blood pressure `?¥ 150 mm Hg OR diastolic blood pressure `?¥ 100 mm Hg (antihypertensive therapy to achieve these parameters is allowable) • History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders within 1 year of enrollment - Recent major surgical procedure within 28 days prior to enrollment or not yet recovered from prior major surgery (For the full list see protocol.)

发起方

Amgen Inc.