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NCT03580655 · OUTCOME

Percent Change From Baseline in Bone Marrow Mast Cells

(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 · Source last updated 2026-04-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Percent Change
Interval / dispersion
Standard Deviation
Time frame
Baseline up to Month 65

What was measured

Bone marrow biopsies and aspirates and peripheral blood smears were obtained for systemic mastocytosis response assessment according to mIWG-MRT-ECNM criteria. Each cycle is 28 days long.

Analysis population: Safety Population: all participants who received ≥1 dose of avapritinib. Here, 'Number Analyzed' signifies those participants evaluable for this outcome measure at the specified timepoint.

Groups in this outcome

Avapritinib

Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Avapritinib84

Reported measurements

Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib84
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-63.7439.445Not reportedNot reportedNot reported
Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib84
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-71.1235.602Not reportedNot reportedNot reported
Cycle 11, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib69
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-73.1049.885Not reportedNot reportedNot reported
Cycle 17, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib61
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-81.3332.377Not reportedNot reportedNot reported
Cycle 23, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib54
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-80.8429.283Not reportedNot reportedNot reported
Cycle 29, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib40
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-78.9029.181Not reportedNot reportedNot reported
Cycle 35, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib34
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-83.5328.316Not reportedNot reportedNot reported
Cycle 41, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib25
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-83.3221.374Not reportedNot reportedNot reported
Cycle 47, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib19
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-81.3821.656Not reportedNot reportedNot reported
Cycle 53, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib16
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-75.8329.094Not reportedNot reportedNot reported
Cycle 59, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib10
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-79.5521.921Not reportedNot reportedNot reported
Cycle 65, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib3
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-68.0326.781Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.445
        value
        -63.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        84
      units
      Participants
    title
    Cycle 3, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.602
        value
        -71.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        84
      units
      Participants
    title
    Cycle 7, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.885
        value
        -73.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      units
      Participants
    title
    Cycle 11, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.377
        value
        -81.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      units
      Participants
    title
    Cycle 17, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.283
        value
        -80.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    Cycle 23, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.181
        value
        -78.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      units
      Participants
    title
    Cycle 29, Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.316
        value
        -83.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    Cycle 35, Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.374
        value
        -83.32
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    Cycle 41, Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.656
        value
        -81.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      units
      Participants
    title
    Cycle 47, Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.094
        value
        -75.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Cycle 53, Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.921
        value
        -79.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Cycle 59, Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.781
        value
        -68.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Cycle 65, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      84
    units
    Participants
description
Bone marrow biopsies and aspirates and peripheral blood smears were obtained for systemic mastocytosis response assessment according to mIWG-MRT-ECNM criteria. Each cycle is 28 days long.
dispersion Type
Standard Deviation
groups
  1. description
    Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
    id
    OG000
    title
    Avapritinib
param Type
MEAN
population Description
Safety Population: all participants who received ≥1 dose of avapritinib. Here, 'Number Analyzed' signifies those participants evaluable for this outcome measure at the specified timepoint.
reporting Status
POSTED
time Frame
Baseline up to Month 65
title
Percent Change From Baseline in Bone Marrow Mast Cells
type
SECONDARY
unit Of Measure
Percent Change

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice