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NCT03580655 · ClinicalTrials.gov registry record · Phase 2
(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
A Phase 2 study of Systemic Mastocytosis With an Associated Hematologic Neoplasm and Aggressive Systemic Mastocytosis, sponsored by Blueprint Medicines Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT03580655 is a Phase 2 study of Systemic Mastocytosis With an Associated Hematologic Neoplasm and Aggressive Systemic Mastocytosis that has completed, run by Blueprint Medicines Corporation. The registered enrollment target is 107 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT03580655, a Phase 2 study of Systemic Mastocytosis With an Associated Hematologic Neoplasm and Aggressive Systemic Mastocytosis, has completed, sponsored by Blueprint Medicines Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. 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 24 total studies on file at ClinicalTrials.gov.
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.
NCT03580655 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, New York, Texas.
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.
What interventions are being tested in trial NCT03580655?
The interventions under investigation include: Avapritinib (DRUG).
Who is sponsoring clinical trial NCT03580655?
This trial is sponsored by Blueprint Medicines Corporation, which has 24 total clinical trials registered on ClinicalTrials.gov.
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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