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NCT03353753 · OUTCOME

Progression-Free Survival (PFS)

Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies · Source last updated 2022-11-21

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

Measure
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].

What was measured

PFS was defined as the time interval between the date of randomization and the earliest documented evidence of the first disease progression based on the independent radiologic review or death due to any cause on initially assigned study treatment, whichever comes earlier, assessed at 26, 39, and 52 weeks.

Analysis population: ITT Population

Groups in this outcome

Ripretinib

Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).

Placebo

Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).

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

Analysis denominator · Participants

GroupSource count
Ripretinib85
Placebo44

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ripretinib27.6Not reported20.029.9Not reported
Placebo4.1Not reported4.07.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.25
    estimate Comment
    Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Two-sided P-value
    param Type
    Hazard Ratio, log
    param Value
    0.15
    statistical Comment
    Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.25
    estimate Comment
    Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Two-sided P-value
    param Type
    Hazard Ratio, log
    param Value
    0.15
    statistical Comment
    Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.0
        upper Limit
        29.9
        value
        27.6
      2. group Id
        OG001
        lower Limit
        4.0
        upper Limit
        7.3
        value
        4.1
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    2. group Id
      OG001
      value
      44
    units
    Participants
description
PFS was defined as the time interval between the date of randomization and the earliest documented evidence of the first disease progression based on the independent radiologic review or death due to any cause on initially assigned study treatment, whichever comes earlier, assessed at 26, 39, and 52 weeks.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
    id
    OG000
    title
    Ripretinib
  2. description
    Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
ITT Population
reporting Status
POSTED
time Frame
From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
title
Progression-Free Survival (PFS)
type
PRIMARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice