NCT03353753 · OUTCOME

Overall Survival (OS)

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 the date of randomization to the date of death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].

What was measured

Overall Survival (OS) was defined as the interval between the date of randomization until the date of death or the date of last follow-up.

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

Group	Source count
Ripretinib	85
Placebo	44

Reported measurements

Source class 1

Values in weeks · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ripretinib	65.6	Not reported	53.6	65.6	Not reported
Placebo	28.6	Not reported	17.9	50.4	Not reported

Source statistical analyses

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

ci Lower Limit
0.21
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.62
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
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0004
p Value Comment
Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR and OS.
param Type
Hazard Ratio (HR)
param Value
0.36
statistical Comment
Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.21
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.62
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
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0004
p Value Comment
Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR and OS.
param Type
Hazard Ratio (HR)
param Value
0.36
statistical Comment
Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
53.6
upper Limit
65.6
value
65.6
group Id
OG001
lower Limit
17.9
upper Limit
50.4
value
28.6

denoms

counts
group Id
OG000
value
85
group Id
OG001
value
44
units
Participants

description

Overall Survival (OS) was defined as the interval between the date of randomization until the date of death or the date of last follow-up.

dispersion Type

95% Confidence Interval

groups

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
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 the date of randomization to the date of death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

weeks

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Preserved source evidence · Not medical advice