Global Phase II Study Sample Clauses
Global Phase II Study. The global open-label single arm Phase II study of savolitinib in patients with locally advanced or metastatic PRCC was initiated in May 2014, reaching a total of 22 clinical centers in the U.S., Canada, UK, and Spain, and completing enrollment of 109 PRCC patients in October 2015. This Phase II study is the largest prospective clinical study ever conducted in PRCC. The primary objective of the study is to assess the anti-tumor activity of savolitinib in patients with PRCC, with secondary assessment objectives including median Progression Free Survival, duration of response, safety and tolerability, and pharmacokinetics and pharmacodynamics. Importantly, tumor samples from each patient were concurrently subjected to molecular analysis to determine c-Met status in order to better understand the relationship between c-Met aberration and clinical outcome. The results of the Phase II study will be presented at an upcoming scientific meeting. The savolitinib c-Met-driven PRCC pivotal Phase III study will be the first molecularly selected trial in RCC. The molecular analysis of each patient in the PRCC Phase II study has provided an understanding of the biomarker and selection criteria needed to identify PRCC patients most likely to benefit from treatment with savolitinib. AstraZeneca and Foundation Medicine, Inc. (Nasdaq: FMI) have an agreement to develop companion diagnostic assays to facilitate personalized medicine in oncology by identifying patients most likely to benefit from novel targeted therapies, including savolitinib. The companion diagnostic assays assess multiple cancer-related genes as well as classes of genomic alterations, and are being developed in parallel with the clinical development of savolitinib as part of a coordinated regulatory strategy. The PRCC Phase III companion diagnostic platform will be largely similar for other indications such as NSCLC and gastric cancer. Under the 2011 Agreement, we granted to AstraZeneca co-exclusive, worldwide rights to manufacture and commercialize savolitinib for all diagnostic, prophylactic and therapeutic uses. AstraZeneca paid $20 million upon execution and agreed to pay royalties and additional amounts upon the achievement of development and sales milestones. As of June 30, 2016 we had received a further $20 million in milestone payments. We may potentially receive future clinical development and first sales milestones of up to $100 million for clinical development and initial sales of savolitinib, pl...
Global Phase II Study. The global open-label single arm Phase II study of savolitinib in patients with locally advanced or metastatic PRCC was initiated in May 2014, reaching a total of 22 clinical centers in the U.S., Canada, UK, and Spain, and completing enrollment of 109 PRCC patients in October 2015. This Phase II study is the largest prospective clinical study ever conducted in PRCC. The primary objective of the study is to assess the anti-tumor activity of savolitinib in patients with PRCC, with secondary assessment objectives including median Progression Free Survival, duration of response, safety and tolerability, and pharmacokinetics and pharmacodynamics. Importantly, tumor samples from each patient were concurrently subjected to molecular analysis to determine c- Met status in order to better understand the relationship between c-Met aberration and clinical outcome. The results of the Phase II study will be presented at an upcoming scientific meeting.