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NCT03580655 · OUTCOME

Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden

(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 aspirate and PB samples were collected to characterize the KIT D816V mutation allele fraction. 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
Avapritinib97

Reported measurements

Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Avapritinib92
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-14.6521.049Not reportedNot reportedNot reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib87
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-41.6823.171Not reportedNot reportedNot reported
Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib97
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-54.3231.272Not reportedNot reportedNot reported
Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib85
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-65.4632.953Not reportedNot reportedNot reported
Cycle 11, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib85
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-67.7730.802Not reportedNot reportedNot reported
Cycle 17, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib72
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-77.2526.783Not reportedNot reportedNot reported
Cycle 23, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib63
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-77.0929.838Not reportedNot reportedNot reported
Cycle 29, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib52
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-80.9729.775Not reportedNot reportedNot reported
Cycle 35, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib39
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-81.9331.110Not reportedNot reportedNot reported
Cycle 41, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib41
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-85.3124.911Not reportedNot reportedNot reported
Cycle 47, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib31
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-81.7628.490Not reportedNot reportedNot reported
Cycle 53, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib25
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-76.2734.561Not reportedNot reportedNot reported
Cycle 59, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib10
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-64.4237.677Not reportedNot reportedNot reported
Cycle 65, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib5
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-47.5847.893Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.049
        value
        -14.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      units
      Participants
    title
    Cycle 1, Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.171
        value
        -41.68
    denoms
    1. counts
      1. group Id
        OG000
        value
        87
      units
      Participants
    title
    Cycle 2, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.272
        value
        -54.32
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      units
      Participants
    title
    Cycle 3, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.953
        value
        -65.46
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      units
      Participants
    title
    Cycle 7, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.802
        value
        -67.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      units
      Participants
    title
    Cycle 11, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.783
        value
        -77.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        72
      units
      Participants
    title
    Cycle 17, Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.838
        value
        -77.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    Cycle 23, Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.775
        value
        -80.97
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Cycle 29, Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.110
        value
        -81.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      units
      Participants
    title
    Cycle 35, Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.911
        value
        -85.31
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      units
      Participants
    title
    Cycle 41, Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.490
        value
        -81.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Cycle 47, Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        34.561
        value
        -76.27
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    Cycle 53, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      97
    units
    Participants
description
Bone marrow aspirate and PB samples were collected to characterize the KIT D816V mutation allele fraction. 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 V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
type
SECONDARY
unit Of Measure
Percent Change

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

Preserved source evidence · Not medical advice