Exelixis Provides Regulatory Update Related To Supplemental New Drug Application For Cabozantinib; Alliance For Clinical Trials In Oncology Independent Data And Safety Monitoring Board Recommends Trial Enrollment To Be Stopped
Exelixis Provides Regulatory Update Related To Supplemental New Drug Application For Cabozantinib; Alliance For Clinical Trials In Oncology Independent Data And Safety Monitoring Board Recommends Trial Enrollment To Be Stopped
伊克力西斯就卡博替尼補充新藥申請提供監管更新;臨床腫瘤聯盟獨立數據和安全監控委員會建議停止試驗招募
The Alliance For Clinical Trials In Oncology Independent Data And Safety Monitoring Board Unanimously Recommended That Enrollment In Cabinet Trial Be Stopped And Randomized Patients Be Unblinded To Therapy With The Allowance For Crossover From Placebo To Cabozantinib Due To The Substantial Improvement In Progression-free Survival (Pfs) Observed At This Interim Analysis.
腫瘤學臨床試驗聯盟獨立數據和安全監測委員會一致建議,由於本中期分析觀察到無進展存活率(Pfs)的顯著改善,因此停止內閣試驗的註冊,允許隨機分組的患者接受治療,允許從安慰劑過渡到卡博贊替尼。