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NCT03580655 · OUTCOME

Percent Change From Baseline in Spleen Volume by Imaging

(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

Assessment of spleen volume was performed using serial imaging with MRI. Response was defined as ≥35% reduction in spleen volume (PR) or resolution of palpable splenomegaly (CR). 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-28.4726.817Not reportedNot reportedNot reported
Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib67
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-35.7726.770Not reportedNot reportedNot reported
Cycle 11, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib73
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-38.7128.700Not reportedNot reportedNot reported
Cycle 17, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib62
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-47.5323.957Not reportedNot reportedNot reported
Cycle 23, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib56
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-44.8924.377Not reportedNot reportedNot reported
Cycle 29, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib44
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-44.3032.952Not reportedNot reportedNot reported
Cycle 35, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib36
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-45.0032.274Not reportedNot reportedNot reported
Cycle 41, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib36
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-51.3325.812Not reportedNot reportedNot reported
Cycle 47, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib30
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-52.4524.580Not reportedNot reportedNot reported
Cycle 53, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib20
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-42.8545.498Not reportedNot reportedNot reported
Cycle 59, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib11
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-40.3528.396Not reportedNot reportedNot reported
Cycle 65, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib4
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-40.2711.884Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.817
        value
        -28.47
    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
        26.770
        value
        -35.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      units
      Participants
    title
    Cycle 7, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.700
        value
        -38.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      units
      Participants
    title
    Cycle 11, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.957
        value
        -47.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      units
      Participants
    title
    Cycle 17, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.377
        value
        -44.89
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      units
      Participants
    title
    Cycle 23, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.952
        value
        -44.30
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      units
      Participants
    title
    Cycle 29, Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.274
        value
        -45.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Cycle 35, Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.812
        value
        -51.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Cycle 41, Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.580
        value
        -52.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      units
      Participants
    title
    Cycle 47, Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.498
        value
        -42.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Cycle 53, Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.396
        value
        -40.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Cycle 59, Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.884
        value
        -40.27
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 65, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      84
    units
    Participants
description
Assessment of spleen volume was performed using serial imaging with MRI. Response was defined as ≥35% reduction in spleen volume (PR) or resolution of palpable splenomegaly (CR). 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 Spleen Volume by Imaging
type
SECONDARY
unit Of Measure
Percent Change

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

Preserved source evidence · Not medical advice