Date: 2015-10-26
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Astellas Pharma (Japan)
Product: ASP8273 - naquotinib mesylate
Action
mechanism: tyrosine kinase inhibitor/EGFR inhibitor. ASP8273 is an orally available, third-generation, mutant-selective, epidermal growth factor receptor (EGFR) inhibitor. It covalently binds to and inhibits the activity of mutant forms of EGFR, including the T790M EGFR mutant, thereby preventing EGFR-mediated signaling.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: Australia, Belgium, Canada, Chile, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Portugal, Romania, Singapore, Spain, Taiwan, Ukraine, UK, USA
Trial
details: The purpose of the study is to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. This study will also assess Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters. (NCT02588261)
Latest
news: * On October 10, 2015, a Phase 3 trial sponsored by Astellas Pharma was published on the NIH website ClinicalTrials.gov for ASP8273 - naquotinib mesylate and is currently recruiting participants.
