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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

伊克力西斯就卡博替尼补充新药申请提供监管更新;临床肿瘤联盟独立数据和安全监控委员会建议停止试验招募
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.

临床肿瘤联盟独立数据与安全监测委员会一致推荐暂停《Cabinet试验》的招募,对随机分组的患者解盲,允许从安慰剂交叉到卡泊替尼,因为在这次中期分析中观察到了显著的无进展生存(PFS)改善。

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