ALK/EGFR抑制剂- AP26113（更新了2013年进展）

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加量以后副作用如何？

Advancing AP26113

&#8226atient enrollment and follow up in the Phase 2 portion of the Phase 1/2 clinical trial of AP26113 are ongoing, and we plan to begin a pivotal Phase 2 trial of AP26113 in ALK+ non-small cell lung cancer (NSCLC) patients resistant to crizotinib later in the first quarter of this year. We expect this trial to be the basis for our initial registration of AP26113.
•The planned pivotal trial for AP26113 will be global in design and is expected to enroll approximately 220 patients. All patients in the trial will begin at a dose of 90 mg per day and after one week, will be randomized one-to-one, increasing half of the patients to 180 mg per day, while the other half remain at 90 mg per day. Patients will be evaluated for objective response rate as the primary end-point.
•We anticipate presenting clinical updates on AP26113 at the 2014 annual meetings of the American Society of Clinical Oncology and the European Society of Medical Oncology.

老马 发表于 2014-2-26 08:04
Advancing AP26113

&#8226atient enrollment and follow up in the Phase 2 portion of the Phase 1/ ...

&#8226atient enrollment and follow up in the Phase 2 portion of the Phase 1/2 clinical trial of AP26113 are ongoing, and we plan to begin a pivotal Phase 2 trial of AP26113 in ALK+ non-small cell lung cancer (NSCLC) patients resistant to crizotinib later in the first quarter of this year. We expect this trial to be the basis for our initial registration of AP26113.
- AP26113 1/2期临床试验中参与并跟进的患者正在进行第二部分的实验，我们计划将在2014年第一季度展开其对ALK+的非小细胞患者在克唑替尼（Crizotinib）耐药后的二期试验。我们希望此次实验用于AP26113首次登记的基础。

•The planned pivotal trial for AP26113 will be global in design and is expected to enroll approximately 220 patients. All patients in the trial will begin at a dose of 90 mg per day and after one week, will be randomized one-to-one, increasing half of the patients to 180 mg per day, while the other half remain at 90 mg per day. Patients will be evaluated for objective response rate as the primary end-point.
- 计划实验将在全球的220名患者中展开。所有患者将在第一周按照每天90mg一次的剂量给药；一周后将1：1随机分配，一半患者将给药剂量提升至每天180mg，另一半持续上一周每天90mg的剂量。此次实验的主要终点为评估客观缓解率。

•We anticipate presenting clinical updates on AP26113 at the 2014 annual meetings of the American Society of Clinical Oncology and the European Society of Medical Oncology.
- 预计实验结果将在2014年ASCO和ESMO的年会中公布。

      2014年3月28日上午，患肺腺癌脑膜转移的爱人服用特罗凯联合184 十五天后，头部有有嗡嗡响的感觉，换服刚买回配好的26113（100毫克）空腹服用20分钟后，腹部拧疼，周身拘促难受似打吗啡止疼时间过点的那种感觉病人难以耐受，给予服用腹可安和半碗温开水半个小时后，不适症状逐渐缓解恢复。用药后5小时后感觉症状比前减轻。

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