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

Benzinga · 2024/11/27 05:14

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.

臨床腫瘤聯盟獨立數據與安全監測委員會一致推薦暫停《Cabinet試驗》的招募，對隨機分組的患者解盲，允許從安慰劑交叉到卡泊替尼，因爲在這次中期分析中觀察到了顯著的無進展生存（PFS）改善。

譯文內容由第三人軟體翻譯。

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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

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