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NCT01271712 · OUTCOME

Tumor Response

Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST) · Source last updated 2021-01-29

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 randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year

What was measured

Tumor Response of a subject was defined as the best tumor response (Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\], Partial Response \[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\], Stable Disease \[SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\], or Progressive Disease \[PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.\]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation.

Analysis population: Full Analysis Set (FAS)

Groups in this outcome

Regorafenib (Stivarga, BAY73-4506)

Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks

Placebo

Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks

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

Analysis denominator · Participants

GroupSource count
Regorafenib (Stivarga, BAY73-4506)133
Placebo66

Reported measurements

Complete Response (CR)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regorafenib (Stivarga, BAY73-4506)0Not reported00Not reported
Placebo0Not reported00Not reported
Partial Response (PR)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regorafenib (Stivarga, BAY73-4506)4.5Not reported1.79.6Not reported
Placebo1.5Not reported08.2Not reported
Stable Disease (SD)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regorafenib (Stivarga, BAY73-4506)71.4Not reported63.078.9Not reported
Placebo33.3Not reported22.246.0Not reported
Progressive Disease (PD)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regorafenib (Stivarga, BAY73-4506)21.1Not reported14.529.0Not reported
Placebo63.6Not reported50.975.1Not reported
Not Assessable
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regorafenib (Stivarga, BAY73-4506)3.0Not reported0.87.5Not reported
Placebo1.5Not reported08.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.7
        upper Limit
        9.6
        value
        4.5
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        8.2
        value
        1.5
    title
    Partial Response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        63.0
        upper Limit
        78.9
        value
        71.4
      2. group Id
        OG001
        lower Limit
        22.2
        upper Limit
        46.0
        value
        33.3
    title
    Stable Disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.5
        upper Limit
        29.0
        value
        21.1
      2. group Id
        OG001
        lower Limit
        50.9
        upper Limit
        75.1
        value
        63.6
    title
    Progressive Disease (PD)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8
        upper Limit
        7.5
        value
        3.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        8.2
        value
        1.5
    title
    Not Assessable
denoms
  1. counts
    1. group Id
      OG000
      value
      133
    2. group Id
      OG001
      value
      66
    units
    Participants
description
Tumor Response of a subject was defined as the best tumor response (Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\], Partial Response \[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\], Stable Disease \[SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\], or Progressive Disease \[PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.\]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    OG000
    title
    Regorafenib (Stivarga, BAY73-4506)
  2. description
    Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
Full Analysis Set (FAS)
reporting Status
POSTED
time Frame
From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year
title
Tumor Response
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice