EUCTR2015-003607-30-IT进行中（未招募）1 期
A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma -
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
- 350
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
- •1. = 18-years of age.
- •2. Subjects with metastatic RCC who have failed 2 or 3 prior systemic regimens, one of which includes a VEGFR TKI other than sorafenib or tivozanib.
- •3. Subjects must have recovered from the AEs of prior therapy or returned to baseline. Controlled AEs such as hypothyrodism or hypertension are permitted.
- •4. Histologically or cytologically confirmed RCC with a clear cell component (subjects with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, and unclassified RCC are excluded).
- •5. Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •7. Life expectancy = 3 months.
- •8. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment.
- •9. Ability to give written informed consent and comply with protocol.
- •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 175
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 175
排除标准
- •1. Prior treatment with sorafenib or tivozanib.
- •2. More than 3 prior regimens for metastatic RCC.
- •3. Known central nervous system (CNS) metastases other than stable, treated brain metastases. Subjects with previously treated brain metastasis will be allowed if the brain metastasis has been stable by neuroimaging without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
- •4. Significant cardiovascular disease
- •5. Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
- •6. Significant bleeding disorders
- •7. Currently active second primary malignancy
- •8. Pregnant or lactating females.
- •9. Participation in another interventional protocol.
研究者
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