A Randomized, International, Open-Label, Multi-Centre, 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 Experience Grade 2 or Higher Adverse Events during the First 12 Months of Treatment with Vandetanib

AstraZeneca AB0 个研究点目标入组 154 人开始时间: 2011年3月31日最近更新: 2012年9月11日

适应症

试验速览

暂无简介。

•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 patient's medical chart
•WHO or ECOG Performance status 0-2
•Negative pregnancy test (urine or serum) for female patients of childbearing potential
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range
•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 patient's medical chart
•WHO or ECOG Performance status 0-2
•Negative pregnancy test (urine or serum) for female patients of childbearing potential
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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 =2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhytmia
•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 =2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhytmia

发起方