EUCTR2011-000493-56-DE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
- 性别
- All
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
相似试验
进行中（未招募）
1 期
An evaluation of the investigational drug GDC-0980 in patients with metastatic kidney cancer who have already received up to three therapies, with the approved drug everolimus as a comparisoMETASTATIC RENAL CELL CARCINOMAMedDRA version: 14.1 Level: LLT Classification code 10038415 Term: Renal cell carcinoma stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: LLT Classification code 10038407 Term: Renal cell cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: LLT Classification code 10038409 Term: Renal cell carcinoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000493-56-GBGENENTECH, Inc.85
进行中（未招募）
1 期
An evaluation of the investigational drug GDC-0980 in patients with metastatic kidney cancer who have already received up to three therapies, with the approved drug everolimus as a comparisoMETASTATIC RENAL CELL CARCINOMAMedDRA version: 14.0Level: LLTClassification code 10038409Term: Renal cell carcinoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: LLTClassification code 10038407Term: Renal cell cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000493-56-ESGENENTECH, Inc.85
进行中（未招募）
1 期
A Study of GDC-0810 versus Fulvestrant in Postmenopausal Women with Advanced or Metastatic ER+/HER2- Breast Cancer Resistant To Aromatase Inhibitor TherapyAdvanced or Metastatic ER+/HER2- Breast CancerMedDRA version: 18.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864EUCTR2015-000106-19-ESGenentech, Inc152
进行中（未招募）
1 期
A Study of GDC-0810 versus Fulvestrant in Postmenopausal Women with Advanced or Metastatic ER+/HER2- Breast Cancer Resistant To Aromatase Inhibitor TherapyEUCTR2015-000106-19-DEGenentech, Inc152
已完成
2 期
AN OPEN-LABEL, PHASE Ia/Ib/IIa STUDY OF GDC 0810 SINGLE AGENT OR IN COMBINATION WITH PALBOCICLIB AND/OR AN LHRH AGONIST IN WOMEN WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR POSITIVE BREAST CANCEREstrogen receptor positive breast cancer10006291NL-OMON45124Genentech, Inc4