TRIAL DETAIL

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)

Drug:
Trial Name:
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)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
3
Start Date 08/01/2023
Age of Trial (yrs) .7
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
DCC-2618-03-003
Sponsor:
Deciphera Pharmaceuticals, Inc.
Patient Contact:
Clinical Team 785-830-2100 Clinicaltrials@deciphera.com
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
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)

Trial Links

Trial Results

Drug Information

4/1/2009 AACR #3733- Small molecule modulators of KIT kinase for treatment of gastrointestinal stromal tumors (GIST). Inhibitors of juxtamembrane domain, D816V, T670I and V654A mutant forms
 
6/1/2010 ASCO - In vitro activity of novel KIT/PDGFRA switch pocket kinase inhibitors against mutations associated with drug-resistant GI stromal tumors.
 
Deciphera pipeline description of DCC-2618
 
Deciphersa Switch Pocket Type II Inhibitors graphics
 
Translational Data Presented at the 2017 American Association for Cancer Research (AACR) Annual Meeting
 
12/1/2016 EEORTC-NIH-AACR meeting abstract
 
QINLOCK website (Deciphera). Manufacturers website
 
Ripretinib prescribing information
 
Access to QINLOCK (Decipheraaccesspoint.com)
 
Dermatopathological review of cutaneous squamous cell carcinoma events in patients with GIST treated with ripretinib
 

Trial Sites

Name
Address
City
State
Zip
Country
Portland
OR
97239
USA
610 University Ave
Toronto
ON
M5G 2M9
Canada
Cleveland
OH
44195
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
1275 York Ave
New York
NY
10065
USA