An Open-Label Clinical Trial Evaluating the Safety and Pharmacodynamics of Sirolimus and Panitumumab in Subjects With Advanced Non-Small Cell Lung Cancer

Amgen0 个研究点开始时间: 2006年3月1日最近更新: 2018年9月6日

适应症

试验速览

To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC

•Histologically- or cytologically-confirmed diagnosis of stage IIIB or IV Non-Small Cell Lung Cancer
•Received only one prior treatment (not including radiation)
•Measurable disease per Response Evaluation Criteria in Solid Tumors Group (RECIST) guidelines
•Life expectancy of ≥ 4 months
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Adequate hematologic, renal and hepatic function
•Serum-fasting cholesterol ≤ 300 mg/dL Serum-fasting triglycerides ≤ 2.5 X ULN

•Brain metastases requiring treatment
•History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline
•Systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days before enrollment
•Prior epidermal growth factor receptor targeting agents with the exception of the small molecule EGFr tyrosine kinase inhibitors
•Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short serum half-life (less than 1 week) within 30 days before enrollment, or prior experimental or approved proteins/antibodies with longer serum half-life within 6 weeks before enrollment
•Prior therapy with sirolimus, sirolimus analogs
•Immunosuppressive agents within 28 days before enrollment

safety within the first 3 weeks

发起方

申办方类型

Industry