Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
(PATHFINDER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis
NCT03580655 · View on ClinicalTrials.gov ↗
Study 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)
Conditions Studied
Interventions
- DRUG Avapritinib
Study Locations (20)
Other
- Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie — Vienna
- Odense University Hospital, Department of Haematology — Odense
- Hôpital Necker-Enfants Malades — Paris
- CHU Toulouse - Hôpital Larrey — Toulouse
- Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltranslplantation — Aachen
- Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie — Hamburg
- Universitätsklinikum Leipzig, Medizinische Klinik und Poliklinik I - Hämatologie und Zelltherapie, lnternistische Onkologie, Hämostaseologie — Leipzig
New York
- Roswell Park Comprehensive Cancer Center — Buffalo
- Herbert Irving Comprehensive Cancer Center — New York
Texas
- University of Texas, MD Anderson Cancer Center — Houston
- Mays Cancer Center — San Antonio
California
- Stanford Cancer Institute — Stanford
Illinois
- Rush University Medical Center — Chicago
Kansas
- The University of Kansas Cancer Center — Westwood
Massachusetts
- Dana Farber Cancer Institute — Boston
Michigan
- University of Michigan — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2018-11-21 |
| Est. Completion | 2024-12-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03580655
The ClinicalTrials.gov registry entry for NCT03580655 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Blueprint Medicines Corporation, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Systemic Mastocytosis With an Associated Hematologic Neoplasm appearing as the primary indexed condition, and to 1 intervention — of which Avapritinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03580655 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03580655 about?
NCT03580655 is a clinical study titled "(PATHFINDER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis". 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)
What is the current status of trial NCT03580655?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2018-11-21. Estimated completion is 2024-12-18.
What conditions does trial NCT03580655 study?
This clinical trial studies the following conditions: Systemic Mastocytosis With an Associated Hematologic Neoplasm, Aggressive Systemic Mastocytosis, Mast Cell Leukemia, Advanced Systemic Mastocytosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03580655?
The interventions under investigation include: Avapritinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03580655?
This trial is sponsored by Blueprint Medicines Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03580655 being conducted?
This trial has 20 study locations across California, Illinois, Kansas, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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