A Phase 3 Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib (INSIGHT)

A Phase 3 Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib (INSIGHT)

Gastrointestinal Stromal Tumor

Recruiting

3

Start Date 08/01/2023

Age of Trial (yrs) .8

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

DCC-2618-03-003

Deciphera Pharmaceuticals, Inc.

Clinical Team 785-830-2100 Clinicaltrials@deciphera.com

Randomized

Oral

Brief Summary:
This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.

Partial Criteria (see clinicaltrials.gov listing for full criteria)

Partial Inclusion Criteria: (see clinicaltrials.gov listing for full criteria)

Male or female ≥18 years of age.
Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample. (Circulating tumor DNA)
Participants must have advanced GIST and radiologic progression on imatinib treatment.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.

Partial Exclusion Criteria: (see clinicaltrials.gov listing for full criteria)

History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a ctDNA sample. (Circulating Tumor DNA)