Date: 2014-04-07
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Novartis (Switzerland)
Product: EGF816 (nazartinib)
Action
mechanism: tyrosine kinase inhibitor/EGFR inhibitor. EGF816 is an orally available, irreversible, third-generation, mutant-selective epidermal growth factor receptor (EGFR) inhibitor. Upon oral administration, EGF816 covalently binds to and inhibits the activity of mutant forms of EGFR, including the T790M EGFR mutant, thereby preventing EGFR-mediated signaling. EGFR, a receptor tyrosine kinase mutated in many tumor cell types, plays a key role in tumor cell proliferation and tumor vascularization. EGF816 preferentially inhibits mutated forms of EGFR including T790M, a secondarily acquired resistance mutation, and may have therapeutic benefits in tumors with T790M-mediated resistance when compared to other EGFR tyrosine kinase inhibitors.
Disease: advanced non-small cell lung cancer
Therapeutic area: Cancer - Oncology
Country: France
Trial
details: This phase phase 1-2 multicenter, open-label study is to estimate the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) (Phase l part) of EGF816 and to investigate the anti-tumor activity of EGF816 (Phase II part). (NCT02108964)
Latest
news: * On April 7, 2014, a Phase I trial sponsored by Novartis was published on the NIH website ClinicalTrials.gov for EGF816 and is currently recruiting participants.
