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NCT03673501 · OUTCOME

Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib · Source last updated 2026-02-05

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)

What was measured

PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Analysis population: The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.

Groups in this outcome

Ripretinib

Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles

Sunitinib

Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.

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

Analysis denominator · Participants

GroupSource count
Ripretinib163
Sunitinib164

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ripretinib8.3Not reported6.813.3Not reported
Sunitinib7.0Not reported5.610.9Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3598
    param Type
    Hazard Ratio (HR)
    param Value
    0.88
    statistical Comment
    Strata: by intolerance to imatinib treatment
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3598
    param Type
    Hazard Ratio (HR)
    param Value
    0.88
    statistical Comment
    Strata: by intolerance to imatinib treatment
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.8
        upper Limit
        13.3
        value
        8.3
      2. group Id
        OG001
        lower Limit
        5.6
        upper Limit
        10.9
        value
        7.0
denoms
  1. counts
    1. group Id
      OG000
      value
      163
    2. group Id
      OG001
      value
      164
    units
    Participants
description
PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
    id
    OG000
    title
    Ripretinib
  2. description
    Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
    id
    OG001
    title
    Sunitinib
param Type
MEDIAN
population Description
The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
reporting Status
POSTED
time Frame
From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
title
Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice