NCT03673501 · STUDY IN CONTEXT

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.

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primary · POSTED

PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) Gastrointestinal stromal tumor (GIST) specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. Patients in this population will be analyzed according to the treatment they were scheduled to receive.

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secondary · POSTED

ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as \>=30% decrease in the sum of the longest diameter of target lesions.

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secondary · POSTED

ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as \>=30% decrease in the sum of the longest diameter of target lesions.

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secondary · POSTED

OS was defined as the time from the date of randomization until death due to any cause.

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secondary · POSTED

OS was defined as the time from the date of randomization until death due to any cause.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-gastrointestinal-stromal-tumors
nct id: NCT03673501
trial label: A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0000
source section id
NCT03673501-om-0000
source outcome index
0
endpoint
Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population
endpoint definition
PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
time origin
From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0001
source section id
NCT03673501-om-0001
source outcome index
1
endpoint
Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population
endpoint definition
PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) Gastrointestinal stromal tumor (GIST) specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
time origin
From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0002
source section id
NCT03673501-om-0002
source outcome index
2
endpoint
Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population
endpoint definition
ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
time origin
From confirmed CR or PR to disease progression (up to 1.74 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0003
source section id
NCT03673501-om-0003
source outcome index
3
endpoint
Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population
endpoint definition
ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
time origin
From confirmed CR or PR to disease progression (up to 1.74 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0004
source section id
NCT03673501-om-0004
source outcome index
4
endpoint
Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population
endpoint definition
OS was defined as the time from the date of randomization until death due to any cause.
time origin
From date of randomization until death due to any cause (up to 3.33 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0005
source section id
NCT03673501-om-0005
source outcome index
5
endpoint
Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population
endpoint definition
OS was defined as the time from the date of randomization until death due to any cause.
time origin
From date of randomization until death due to any cause (up to 3.33 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0000
arm key
OG000
arm label
Ripretinib
regimen
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
analyzed count
163
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0000
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
analyzed count
164
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0001
arm key
OG000
arm label
Ripretinib
regimen
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
analyzed count
226
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0001
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
analyzed count
227
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0002
arm key
OG000
arm label
Ripretinib
regimen
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
analyzed count
163
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0002
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
analyzed count
164
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0003
arm key
OG000
arm label
Ripretinib
regimen
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
analyzed count
226
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0003
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
analyzed count
227
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0004
arm key
OG000
arm label
Ripretinib
regimen
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
analyzed count
163
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0004
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
analyzed count
164
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0005
arm key
OG000
arm label
Ripretinib
regimen
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
analyzed count
226
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
outcome key
om-0005
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
analyzed count
227
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03673501-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
harm key
EG000
source section id
NCT03673501-ae
event group key
EG000
event group label
Ripretinib
serious affected
64
serious at risk
223
other affected
221
other at risk
223
frequency threshold
5
collection period
Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
event definition
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT03673501
harm key
EG001
source section id
NCT03673501-ae
event group key
EG001
event group label
Sunitinib
serious affected
61
serious at risk
221
other affected
219
other at risk
221
frequency threshold
5
collection period
Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
event definition
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice