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NCT03731260 · ClinicalTrials.gov registry record · Phase 2
(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis
A Phase 2 study of Indolent Systemic Mastocytosis, sponsored by Blueprint Medicines Corporation.
- Active
- Registry status
- Phase 2
- Development phase
- 251
- Enrollment target
- 20
- Study locations
NCT03731260: Active Phase 2 study of Indolent Systemic Mastocytosis, sponsored by Blueprint Medicines Corporation.
NCT03731260 is a Phase 2 study of Indolent Systemic Mastocytosis that is active but no longer recruiting, run by Blueprint Medicines Corporation. The registered enrollment target is 251 participants, roughly in line with the 263-participant average among 3 other Indolent Systemic Mastocytosis trials with a reported enrollment target. The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03731260, a Phase 2 study of Indolent Systemic Mastocytosis, is active but no longer recruiting, sponsored by Blueprint Medicines Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 251 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Avapritinib
Study Locations (20)
Florida
- Mayo Clinic Florida - Jacksonville
- H. Lee Moffitt Cancer Center - Tampa
Massachusetts
- Brigham & Women's Hospital - Boston
- Dana Farber Cancer Institute - Boston
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic Hospital - Phoenix
California
- Stanford Cancer Institute - Stanford
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Illinois
- Rush University Medical Center - Chicago
Kansas
- University of Kansas Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2019-04-16 |
| Est. Completion | 2027-06-23 |
| Phase | Phase 2 |
What the registry record for NCT03731260 still lists
NCT03731260 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 263-participant average among 3 other Indolent Systemic Mastocytosis trials with a reported enrollment target.
The record links to 1 condition, with Indolent Systemic Mastocytosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03731260 names 20 study sites across 18 states, led by Florida, Massachusetts, Alabama.
Frequently Asked Questions
What is clinical trial NCT03731260 about?
NCT03731260 is a clinical study titled "(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis". This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducte...
What is the current status of trial NCT03731260?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 251 participants. The study started on 2019-04-16. Estimated completion is 2027-06-23.
What conditions does trial NCT03731260 study?
This clinical trial studies the following conditions: Indolent Systemic Mastocytosis.
What interventions are being tested in trial NCT03731260?
The interventions under investigation include: Placebo (DRUG), Avapritinib (DRUG).
Who is sponsoring clinical trial NCT03731260?
This trial is sponsored by Blueprint Medicines Corporation, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03731260 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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