Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03353753 · OUTCOME

Objective Response Rate (ORR)

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
NUMBER
Unit
Percentage of Participants
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

The percentage of patients with a confirmed complete response or PR (CR: Disappearance of all target lesions and non-target lesions (if present at baseline); all lymph nodes must be non-pathological in size) or partial response (PR: \>=30% decrease in the Sum of Diameters of target lesions and non-target lesions non-PD or NE or none at baseline; or target lesions CR and non-target lesions non-CR/Non-PD or NE) based on the independent radiologic review and during the initially assigned study treatment. To be assigned a status of a CR or PR, changes in tumor measurements must be confirmed by repeat CT or MRI assessments that must be performed at least 4 weeks after the criteria for response are first met.

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 Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ripretinib9.4Not reported4.217.7Not reported
Placebo0Not reported0.08.0Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0504
    p Value Comment
    Two-sided P-value
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0504
    p Value Comment
    Two-sided P-value
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.2
        upper Limit
        17.7
        value
        9.4
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        8.0
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    2. group Id
      OG001
      value
      44
    units
    Participants
description
The percentage of patients with a confirmed complete response or PR (CR: Disappearance of all target lesions and non-target lesions (if present at baseline); all lymph nodes must be non-pathological in size) or partial response (PR: \>=30% decrease in the Sum of Diameters of target lesions and non-target lesions non-PD or NE or none at baseline; or target lesions CR and non-target lesions non-CR/Non-PD or NE) based on the independent radiologic review and during the initially assigned study treatment. To be assigned a status of a CR or PR, changes in tumor measurements must be confirmed by repeat CT or MRI assessments that must be performed at least 4 weeks after the criteria for response are first met.
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
NUMBER
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
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice