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发表于 2014-3-25 23:55:02
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来自： 美国
好久因为技术原因我没法登陆 '51奇迹' 了, 感谢网管昨天亲自出马帮助恢复登陆. 有一个AP26113的新闻与大家共享, 要注意的是这个新开"二期关键"药试可能(希望)在全球展开, 但是两种剂量(90毫克 对比 180毫克)是随机化的, 不由病人意志捡选. "二期关键"药试若成功, 此药就可以获批上市, 三期以后补做.
http://www.heraldonline.com/2014 ... -initiation-of.html
ARIAD Announces Initiation of Pivotal Phase 2 ALTA Trial of AP26113 in Patients with Non-Small Cell Lung Cancer
CAMBRIDGE, MASS. — ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the initiation of a pivotal global Phase 2 trial of AP26113 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who were previously treated with crizotinib. The ALTA (ALK in Lung Cancer Trial of AP26113) trial is designed to determine the safety and efficacy of AP26113 in refractory NSCLC patients who test positive for the anaplastic lymphoma kinase (ALK+) oncogene.
“Preliminary data from more than 120 patients studied thus far in the ongoing Phase 1/2 trial have provided important insights into the safety and efficacy of AP26113 and its profile at different dose levels,” said Frank G. Haluska, M.D., Ph.D., senior vice president of clinical research and development and chief medical officer at ARIAD. “We anticipate that the Phase 2 ALTA trial will give us the opportunity to further substantiate these encouraging findings and, importantly, to study two distinct doses of AP26113, which will allow for the potential to optimize its activity in patients with brain metastases.”
Trial Design and Statistical Analysis
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发表于 2013-11-15 15:49:04
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