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NCT01271712 · OUTCOME

Progression-free Survival

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
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)

What was measured

Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as 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. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.

Analysis population: Full Analysis Set (FAS) - defined as all randomized participants.

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

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regorafenib (Stivarga, BAY73-4506)147Not reported122173Not reported
Placebo28Not reported2832Not reported

Source statistical analyses

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

  1. group Description
    The two treatment groups were compared using a stratified log rank test with a one-sided alpha of 0.01 stratified by (3rd vs 4th-line; and geographical region). The null hypothesis that both treatment arms have the same PFS distribution was tested against the alternative hypothesis that the distribution of PFS in the regorafenib arm is different from the control arm according to a proportional hazards relation between the treatment arms.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.000001
    statistical Comment
    stratified
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.185
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.388
    estimate Comment
    regorafenib over placebo
    group Description
    Hazard ratio and its 95% CI (Confidence Interval) was based on stratified Cox Regression Model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.268
    statistical Comment
    stratified
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. group Description
    The two treatment groups were compared using a stratified log rank test with a one-sided alpha of 0.01 stratified by (3rd vs 4th-line; and geographical region). The null hypothesis that both treatment arms have the same PFS distribution was tested against the alternative hypothesis that the distribution of PFS in the regorafenib arm is different from the control arm according to a proportional hazards relation between the treatment arms.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.000001
    statistical Comment
    stratified
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.185
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.388
    estimate Comment
    regorafenib over placebo
    group Description
    Hazard ratio and its 95% CI (Confidence Interval) was based on stratified Cox Regression Model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.268
    statistical Comment
    stratified
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        122
        upper Limit
        173
        value
        147
      2. group Id
        OG001
        lower Limit
        28
        upper Limit
        32
        value
        28
denoms
  1. counts
    1. group Id
      OG000
      value
      133
    2. group Id
      OG001
      value
      66
    units
    Participants
description
Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as 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. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. 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
MEDIAN
population Description
Full Analysis Set (FAS) - defined as all randomized participants.
reporting Status
POSTED
time Frame
From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)
title
Progression-free Survival
type
PRIMARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice