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NCT03353753 · OUTCOME

Time to Tumor Progression (TTP) Based on Independent Radiologic Review

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 [through database cutoff 31-May-2019 (up to approximately 15 months)].

What was measured

TTP is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review.

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
Ripretinib28Not reported20.036.4Not reported
Placebo4.1Not reported4.07.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.0
        upper Limit
        36.4
        value
        28
      2. group Id
        OG001
        lower Limit
        4.0
        upper Limit
        7.6
        value
        4.1
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    2. group Id
      OG001
      value
      44
    units
    Participants
description
TTP is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review.
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 [through database cutoff 31-May-2019 (up to approximately 15 months)].
title
Time to Tumor Progression (TTP) Based on Independent Radiologic Review
type
SECONDARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice