CTRI/2011/07/001930已完成3 期
A Randomized, International, Open-Label Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer (MTC) Experience Grade 2 or Higher AEs in the First 12 Months of Treatment With Vandetanib - Study 88
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Provision of informed consent prior to any study specific procedures
- •- Female or male aged 18 years and over
- •- Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patients medical chart
- •- WHO or ECOG Performance status 0-2
- •- Negative pregnancy test (urine or serum) for female patients of childbearing potential
排除标准
- •- Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
- •- Major surgery within 4 weeks before randomization
- •- The last dose of prior chemotherapy received less than 3 weeks prior to randomization
- •- Radiation therapy not completed prior to the first dose of vandetanib
- •- Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ¡Ý2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhytmia
研究者
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