At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 129 enrolled
Drug / intervention
DCC-2618 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating DCC-2618 and Placebo Oral Tablet for Gastrointestinal Stromal Tumors. Completed, enrolled 129 participants across 35 sites in 13 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Stromal Tumors
CountriesAustralia, Belgium, Canada, Finland, France, Germany, Italy, Netherlands, Poland, Singapore, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartFeb 2018
Primary CompletionMay 2019
Study CompletionMay 2022
TodayJul 2026
First PostedNov 27, 2017
Enrollment StartFeb 27, 2018
Primary CompletionMay 31, 2019
Study CompletionMay 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.6 years ago
Interventions
DCC-2618drug
Oral KIT/PDGFRA kinase inhibitor
Placebo Oral Tabletdrug
Placebo