CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 476 enrolled
Drug / intervention
avapritinib +1 moredrug
Likely dose
avapritinib 300 mgfrom 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.

Search/NCT03465722
NCT03465722Phase 3Completed
CompareCT.gov

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Blueprint Medicines Corporation·interventional·Posted Mar 14, 2018·Updated Oct 6, 2022

In Brief

A Phase 3 clinical trial evaluating avapritinib and regorafenib for GIST. Completed, enrolled 476 participants across 114 sites in 18 countries.

Detailed Summary

This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGIST
CountriesAustralia, Austria, Belgium, Canada, China, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Singapore, South Korea, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 14, 2018
Enrollment StartMar 26, 2018
Primary CompletionMar 9, 2020
Study CompletionSep 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.3 years ago

Interventions

avapritinibdrug

Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.

regorafenibdrug

Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).