NCT03673501

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: Deciphera Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Ripretinib	Oral KIT/PDGFRA kinase inhibitor
DRUG	Sunitinib	Oral receptor tyrosine kinase (RTK) inhibitor

Timeline

• Start date: 2019-02-08
• Primary completion: 2021-09-01
• Completion: 2026-12-01
• First posted: 2018-09-17
• Last updated: 2026-02-05
• Results posted: 2024-01-02

Locations

121 sites across 22 countries: United States, Argentina, Australia, Belgium, Canada, Chile, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study