At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 250 enrolled
Drug / intervention
Avapritinibdrug
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 1 Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Avapritinib for Gastrointestinal Stromal Tumors (GIST) and Other Relapsed or Refractory Solid Tumors. Completed, enrolled 250 participants across 19 sites in 10 countries.
Detailed Summary
This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (formerly BLU-285), administered orally (PO), in adult patients with unresectable GIST or other relapsed or refractory solid tumors. The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Germany, Italy, Netherlands, Poland, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartAug 2015
Primary CompletionMar 2020
Study CompletionJun 2021
TodayJul 2026
First PostedJul 27, 2015
Enrollment StartAug 1, 2015
Primary CompletionMar 6, 2020
Study CompletionJun 3, 2021
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 10.9 years ago
Interventions
Avapritinibdrug
avapritinib tablets