The latest Clinical Trial Protocol article published in Future Oncology describes the rationale, design and endpoints of intrigue, a Phase III study of ripretinib in advanced gastrointestinal stromal tumor (GIST).
Intrigueis a Phase III, randomized, multicenter, open-label study of ripretinib vs sunitinib in patients with advanced GIST after treatment with imatinib.Approximately 358 eligible patients will be randomized in a 1:1 ratio to either ripretinib 150 mg daily continuous 42-day cyclesor sunitinib 50 mg daily for 4 weeks and then 2 weeks off on 42-day cycles. The primary end point is to assess median progression-free survival of ripretinib with key secondary efficacy end points including the assessment of objective response rate and overall survival.
Abstract:Ripretinib (DCC-2618) is a novel, Type II tyrosine switch control inhibitor designed to broadly inhibit activating and drug-resistant mutations in KIT and platelet-derived growth factor receptor alpha. Ripretinib has emerged as a promising investigational agent for the treatment of gastrointestinal stromal tumor (GIST) owing to targeted inhibition of secondary resistance mutations that may develop following treatment with prior line(s) of tyrosine kinase inhibitors. Here we describe the rationale and design of intrigue (NCT03673501), a global, randomized (1:1), open-label, Phase III study comparing the safety and efficacy of ripretinib vs sunitinib in patients with advanced GIST following imatinib. The primary end point is progression-free survival and key secondary objectives include objective response rate and overall survival.