EUCTR2011-000493-56-GB进行中（未招募）1 期
A PHASE II, OPEN-LABEL, RANDOMIZED STUDY OF GDC-0980 VERSUS EVEROLIMUS IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WHO HAVE PROGRESSED ON OR FOLLOWING VEGF-TARGETED THERAPY
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 85
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
- •Histologically or cytologically documented, incurable metastatic renal cell carcinoma with clear-cell component that progressed on or within 6 months of stopping VEGF-targeted therapy
- •Age = 18 years
- •Karnofsky Performance Status Score (KPSS) of = 70%
- •Disease that is measurable per RECIST v1.1
- •Adequate hematologic and end organ function
- •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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •Requirement for chronic antihyperglycemic therapy
- •Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living
- •Decreased oxygen saturation with exercise (pulse oximeter <88%)
- •Previously established diagnosis of pulmonary fibrosis of any cause
- •Current unstable angina
- •History of myocardial infarction within 6 months prior to Day 1
- •New York Heart Association (NYHA) Class II or greater congestive heart failure
- •Clinically significant liver disease
- •Known HIV infection
- •Active infection requiring IV antibiotics
- •Active autoimmune or inflammatory disease that is not controlled by nonsteroidal anti inflammatory drugs; Patients with active Crohn’s disease or ulcerative colitis are not allowed.
- •Pregnancy, lactation, or breastfeeding
- •Leptomeningeal disease as a manifestation of cancer
- •Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control).
- •Hypersensitivity to any rapamycin derivatives or to any excipients of everolimus
- •History of other malignancies <= 5 years of Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
研究者
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