Date: 2016-01-28
Type of information: Clinical trial autorization
phase: 1
Announcement: clinical trial authorization
Company: ArQule (USA - MA)
Product: ARQ 751
Action
mechanism: AKT inhibitor/kinase inhibitor. ARQ 751, is an orally bioavailable inhibitor of the serine/threonine protein kinase AKT (protein kinase B) with potential antineoplastic activity. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications.
Disease: advanced solid tumors
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This study is a dose escalation study of ARQ 751 in adult subjects with advanced solid tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations or PTEN-null (NCT02761694)
Latest
news: * On April 29, 2016, a Phase I trial sponsored by Arqule was published on the NIH website ClinicalTrials.gov for ARQ 751 and is currently recruiting participants.
* On January 28, 2016, ArQule announced a pipeline update for its AKT inhibitors, including ARQ 751. The company received FDA approval of its investigational new drug (IND) application for ARQ 751, a next generation AKT inhibitor, in oncology. As published in PLOSONE, ARQ 751 has demonstrated signal abrogation and efficacy in pre-clinical in vitro and in vivo models harboring AKT1 and PI3K mutations. The company expects to commence a phase 1 trial in oncology during the first half of 2016 targeting AKT1 and PI3K mutations.
