NCT01442090已完成2 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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 主要终点
- DUration of progression-free survival (PFS) as assessed by the investigator using RECIST v1.1
研究概览
简要总结
Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will be randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Disease that is measurable per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- •Karnofsky performance status of greater than or equal to (>=) 70 percent (%)
- •Adequate hematologic and end organ function
- •For female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use two effective forms of contraception and to continue its use for the duration of the study
排除标准
- •Any anti-cancer therapy, including chemotherapy, biologic or other targeted therapy, herbal therapy, hormonal therapy, or radiotherapy, within 5 half-lives (for systemic agents) or 2 weeks, whichever is shorter, prior to Day
- •Certain forms of radiation therapy may be considered for pain palliation if participants are deriving benefit
- •Previously established diagnosis of pulmonary fibrosis of any cause
- •New York Heart Association (NYHA) Class II or greater congestive heart failure
- •History of malabsorption syndrome or other condition that would interfere with enteral absorption
- •Presence of positive test results for hepatitis B (hepatitis B [HB] surface antigen [HBsAg] and/or total HB core antibody [anti-HB-c; both tests are required]) or hepatitis C
- •Known human immunodeficiency virus (HIV) infection
- •Pregnancy, lactation, or breastfeeding
- •Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment
- •Leptomeningeal disease as a manifestation of cancer
- •History of other malignancies less than equal to <= 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
- •Need for current chronic corticosteroid therapy (>= 10 milligrams [mg] of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids for greater than [>] 7 days) or use of other immunosuppressant
研究组 & 干预措施
Everolimus
Active Comparator
Participants will receive everolimus (10 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
干预措施: Everolimus (Drug)
GDC-0980
Experimental
Participants will receive GDC-0980 (40 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
干预措施: GDC-0980 (Drug)
结局指标
主要结局
DUration of progression-free survival (PFS) as assessed by the investigator using RECIST v1.1
时间窗: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
次要结局
- Number of participants with adverse events(up to 30 days after end of treatment (approximately up to 23 months))
- Number of participants with objective tumor response as assessed by the investigator using RECIST v1.1(Baseline until disease progression or death, whichever occurred first (up to approximately 23 months))
- Minimum plasma concentration (Cmin) of GDC-0980(pre-dose on Week 1 Day 1, Week 1 Day 2, Week 3 Day 1 and Week 9 Day 1)
- Maximum plasma concentration (Cmax) of GDC-0980(pre-dose and 1, 2, 4 hours post-dose on Week 1 Day 1, Pre-dose on Week 1 Day 2, pre-dose and 2 hours post dose on Week 3 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months))
- Cmax of everolimus(pre-dose and 2, hours post-dose on Week 1 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months)\n)
- Cmin of everolimus(pre-dose on Week 1 Day 1 and Week 9 Day 1)
- Duration of objective tumour response as assessed by the investigator using RECIST v1.1(Baseline until disease progression or death, whichever occurred first (up to approximately 23 months))
- Duration of overall survival (OS)(Baseline until death (up to approximately 45 months))
研究者
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