At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 107 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.
An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis
In Brief
A Phase 2 clinical trial evaluating Avapritinib for Advanced Systemic Mastocytosis and 3 related conditions. Completed, enrolled 107 participants across 32 sites in 12 countries.
Detailed Summary
This is an open-label, single arm, Phase 2 study evaluating the efficacy and safety of avapritinib (BLU-285) in patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive SM (ASM), SM with associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Systemic Mastocytosis, Aggressive Systemic Mastocytosis, Systemic Mastocytosis With an Associated Hematologic Neoplasm, Mast Cell Leukemia
CountriesAustria, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartNov 2018
Primary CompletionDec 2024
TodayJul 2026
First PostedJul 9, 2018
Enrollment StartNov 21, 2018
Primary CompletionDec 18, 2024
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 8.0 years ago
Interventions
Avapritinibdrug
Avapritinib tablet