2期临床AP26113的数据

查看全部

马上注册，结交更多好友，享用更多功能，让你轻松玩转社区。

您需要登录才可以下载或查看，没有账号？立即注册

x

There is an update for AP26113 with 114 patients. 65 in phase 1 and 49 in phase 2. The most common adverse events were GI related, fatigue an headaches. Adverse events were generally lower than in Ceritinib.

Early onset pulmonary symptoms requiring immediate medical attention happened in 13% of patients at 180mg. None of these symptoms happened in patients at 90mg. So they changed the protocol. Half of the patients will get one week at 90mg and then step it up to 180mg. The other half will start with and stay at 90 mg. I believe that since the changed the protocol, no more early onset pulmonary symptoms have occurred.

Of 38 evaluable ALK+ NSCLC patients with prior Crizotinib the was an ORR of 63%. Duration of response was between 1.6 months and 14.7 months (ongoing). Among 42 evaluable patients median PFS is 47 weeks.

There were 10 patients with untreated brain metastases. 6 had responses in the brain including 4 with undetectable brain mets after treatment.

有一个更新AP26113 114名患者。65在阶段1和阶段2。最常见的不良事件是胃肠道相关,疲劳一个头痛。不良事件通常是低于Ceritinib。　　　　早期肺部症状出现需要立即就医发生在13%的患者在180毫克。没有这些症状发生在患者90毫克。所以他们改变了试验方案。有一半的患者会在90毫克一个星期然后吃180毫克。另一半将开始和呆在90毫克。我相信,自从改变了实验方案,不会出现肺的早期症状发生。　　　　38可评价的ALK+非小细胞肺癌患者之前Crizotinib的ORR为63%。中位缓解持续时间为1.6个月和14.7个月(正在进行)。42可评价的患者平均PFS 47周。有10个治疗脑转移患者。6个有大脑的响应包括4个经过治疗后没有察觉的大脑肿瘤。
入脑率60%