阿斯利康的T790M牛逼新药AZD9291的1期临床结果出来了

υīСКī · 发表于 2013-10-3 13:54:09

认领了认领了

υīСКī · 发表于 2013-10-3 14:19:01

AZD9291 First Time In Patients Ascending Dose Study
AZD9291首次在病患中逐渐增量使用的研究
http://clinicaltrials.gov/show/NCT01802632
Drug: AZD9291
Starting dose 20 mg, administered once daily.
初始剂量20MG每天
If tolerated subsequent cohorts will test increasing doses of AZD9291, until a maximum tolerated dose or maximum feasible dose is defined
耐受结果组群将试验增加AZD9291的剂量，直到得出最大可耐受剂量或最大可行剂量。

D. Ross Camidge, MD, PhD, Director, Thoracic Oncology Clinical Program, University of Colorado Cancer Center, discusses a phase I study looking at AZD9291 in patients with non-small cell lung cancer.（略，第一阶段临床试验用于非小细胞肺癌患者）

AZD9291 is an irreversible inhibitor of epidermal growth factor receptor (EGFR) activating and resistance mutations and seemed to be well tolerated in the trial.
AZD9291是一种作用于EGFR的不可逆抑制剂并防止其突变，而且AZD9291似乎在试验中耐受性表现良好。
Camidge says he found it interesting that some patients did have a little bit of rash, possibly indicating that researchers are already approaching the ideal dose.
CAMIDGE说，他发现一些病人只是略有皮疹，这一现象是有趣的，可能也意味着研究者已经接近理想的剂量。
AZD9291 demonstrated about a 46% response rate overall and about a 56% response rate in T790M+ patients.
试验显示AZD9291的总体有效率为46%，T790M阳性的有效率56%。
Right now, Camidge says, AZD9291 could be a "game-changer," and anticipates a fast-track approval.
CAMIDGE说，AZD9291可能成为一项（治疗上）的颠覆者，并且参与申请快速通道的认证。