NCT03353753

Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies

A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients With AdvanCed Gastrointestinal Stromal TUmorS Who Have Received Treatment With Prior Anticancer Therapies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Deciphera Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	DCC-2618	Oral KIT/PDGFRA kinase inhibitor
DRUG	Placebo Oral Tablet	Placebo

Timeline

• Start date: 2018-02-27
• Primary completion: 2019-05-31
• Completion: 2022-05-11
• First posted: 2017-11-27
• Last updated: 2022-11-21
• Results posted: 2021-04-23

Locations

35 sites across 13 countries: United States, Australia, Belgium, Canada, Finland, France, Germany, Italy, Netherlands, Poland, Singapore, Spain, United Kingdom

Regulatory

• FDA-regulated drug study