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临床试验/EUCTR2011-002957-67-IT
EUCTR2011-002957-67-IT进行中(未招募)不适用

A Randomized, Blinded, Phase 2 Dose-Ranging Study of BMS-936558 (MDX-1106) in Subjects With Progressive Advanced/Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy Revised Protocol 01 incorporating Administrative Letter 01 and Amendment 02

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO0 个研究点目标入组 181 人开始时间: 2011年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
181

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

  • Histologic confirmation of RCC with a clear cell component. • Previous treatment with at least one anti-angiogenic agent • Progressed within 6 months of study enrollment • Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease. • Must have available tumor tissue for submission • Subjects must also meet various laboratory parameters for inclusion (see Protocol section 3.3.1 item 4)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 136
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 45

排除标准

  • Active CNS metastases within 30 days of study enrollment • Subjects with any active autoimmune disease or a history of known autoimmune disease • Subjects with uncontrolled adrenal insufficiency • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured

研究者

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