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临床试验/EUCTR2011-003065-15-FI
EUCTR2011-003065-15-FI进行中(未招募)1 期

PRINCIPAL: A Prospective Observational Study of Real World Treatment Patterns and Treatment Outcomes in Patients with Advanced or Metastatic Renal Cell Carcinoma Receiving Pazopanib - PRINCIPA

ovartis Pharma Services AG0 个研究点目标入组 700 人开始时间: 2013年2月6日最近更新:
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
700

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

  • Inclusion Criteria
  • Specific information regarding warnings, precautions, contraindications, adverse events,
  • and other pertinent information regarding pazopanib that may impact patient treatment is
  • found in the local product labeling.
  • Deviations from inclusion criteria are not allowed because they can potentially jeopardize
  • the scientific integrity of the study. Therefore, adherence to the criteria as specified in the
  • protocol is essential.
  • Patients eligible for enrolment in the study must meet all of the following criteria:
  • Age = 18 years at enrollment
  • Documented diagnosis of advanced and/or metastatic clear cell or predominantly
  • clear cell RCC
  • Clinical decision made to initiate treatment with pazopanib prior to enrollment in the
  • study, but within 30 days of enrollment
  • Willing and able to provide written informed consent
  • 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 600
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • Exclusion Criteria
  • Deviations from exclusion criteria are not allowed because they can potentially
  • jeopardize the scientific integrity of the study. Therefore, adherence to the criteria as
  • specified in the protocol is essential.
  • Patients meeting any of the following criteria must not be enrolled in the study:
  • Patients currently participating in any interventional clinical trials in which treatment
  • regimen and/or monitoring is dictated by a protocol
  • Previous exposure to an investigational or licensed multi-kinase inhibitor or an anti-
  • VEGF angiogenesis inhibitor for advanced or metastatic disease (for guidance, refer
  • to Appendix 1 located in the protocol).
  • Life expectancy < 12 weeks

研究者

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