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NCT03465722 · STUDY IN CONTEXT

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

To demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST following 2 or 3 regimens of prior treatment with a tyrosine kinase inhibitor (TKI), including imatinib, compared to patients treated with regorafenib. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or equal to 2cm in size and be a new GIST active lesion or b) the target lesions must be expanding on at least 2 sequential imaging studies.

Intent-to-Treat Population that included all patients randomized to study.

→

secondary · POSTED

To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib. A complete response (CR) per modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) is defined as complete disappearance of all target lesions. A partial response (PR) is defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Overall Response (OR) = CR + PR

Intent-to-Treat Population that included all patients randomized to study.

→

secondary · POSTED

To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib

Source null

→

secondary · POSTED

The Global Health Status Score is derived from question 29 and 30 on the EORTC-QLQ-C30 tool. The change in score was assessed between baseline and week 12 in patients treated with advanced GIST treated with avapritinib compared to patients treated with regorafenib. The Global Health Status Score score range is 0 to 100 with a higher score indicating better global health status. A positive change indicates improvement in global health status.

Intent-to-Treat Population with both a baseline and a Week 12 measurements.

→

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

EORTC QLQ · European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30). Change in Individual Scores in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
nct id
NCT03465722
qol key
qol-0003
source section id
NCT03465722-om-0003
source outcome index
3
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30). Change in Individual Scores in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib
measure definition
The Global Health Status Score is derived from question 29 and 30 on the EORTC-QLQ-C30 tool. The change in score was assessed between baseline and week 12 in patients treated with advanced GIST treated with avapritinib compared to patients treated with regorafenib. The Global Health Status Score score range is 0 to 100 with a higher score indicating better global health status. A positive change indicates improvement in global health status.
time frame
Difference between baseline and week 12 of treatment
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicating better
population note
Intent-to-Treat Population with both a baseline and a Week 12 measurements.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
nct id
NCT03465722
trial label
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
4
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0000
    source section id
    NCT03465722-om-0000
    source outcome index
    0
    endpoint
    Efficacy of Avapritinib Based on Progression-free Survival (PFS) Determined by Central Radiological Assessment Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST), Version 1.1
    endpoint definition
    To demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST following 2 or 3 regimens of prior treatment with a tyrosine kinase inhibitor (TKI), including imatinib, compared to patients treated with regorafenib. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or equal to 2cm in size and be a new GIST active lesion or b) the target lesions must be expanding on at least 2 sequential imaging studies.
    time origin
    24 Months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-Treat Population that included all patients randomized to study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0001
    source section id
    NCT03465722-om-0001
    source outcome index
    1
    endpoint
    Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1
    endpoint definition
    To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib. A complete response (CR) per modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) is defined as complete disappearance of all target lesions. A partial response (PR) is defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Overall Response (OR) = CR + PR
    time origin
    24 Months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-Treat Population that included all patients randomized to study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0002
    source section id
    NCT03465722-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS) in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib
    endpoint definition
    To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
    time origin
    24 Months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0003
    source section id
    NCT03465722-om-0003
    source outcome index
    3
    endpoint
    European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30). Change in Individual Scores in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib
    endpoint definition
    The Global Health Status Score is derived from question 29 and 30 on the EORTC-QLQ-C30 tool. The change in score was assessed between baseline and week 12 in patients treated with advanced GIST treated with avapritinib compared to patients treated with regorafenib. The Global Health Status Score score range is 0 to 100 with a higher score indicating better global health status. A positive change indicates improvement in global health status.
    time origin
    Difference between baseline and week 12 of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-Treat Population with both a baseline and a Week 12 measurements.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Avapritinib
    regimen
    300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
    analyzed count
    240
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03465722-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Regorafinib
    regimen
    160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
    analyzed count
    236
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03465722-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Avapritinib
    regimen
    300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
    analyzed count
    240
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03465722-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Regorafinib
    regimen
    160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
    analyzed count
    236
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03465722-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Avapritinib
    regimen
    300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
    analyzed count
    240
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03465722-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Regorafinib
    regimen
    160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
    analyzed count
    236
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03465722-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Avapritinib
    regimen
    300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
    analyzed count
    123
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03465722-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Regorafinib
    regimen
    160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
    analyzed count
    138
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03465722-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    harm key
    EG000
    source section id
    NCT03465722-ae
    event group key
    EG000
    event group label
    Avapritinib
    serious affected
    106
    serious at risk
    239
    other affected
    218
    other at risk
    239
    frequency threshold
    5
    collection period
    From the date of first study drug administration to 30 days after last study drug administration, approximately 6 months
    event definition
    The total number of at risk patients includes patients that were randomized to treatment and received at least one dose of treatment. Patients that were randomized by did not receive treatment were excluded from the safety analysis.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    harm key
    EG001
    source section id
    NCT03465722-ae
    event group key
    EG001
    event group label
    Regorafinib
    serious affected
    91
    serious at risk
    234
    other affected
    224
    other at risk
    234
    frequency threshold
    5
    collection period
    From the date of first study drug administration to 30 days after last study drug administration, approximately 6 months
    event definition
    The total number of at risk patients includes patients that were randomized to treatment and received at least one dose of treatment. Patients that were randomized by did not receive treatment were excluded from the safety analysis.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors-stivarga-dbeeb4f0
    nct id
    NCT03465722
    qol key
    qol-0003
    source section id
    NCT03465722-om-0003
    source outcome index
    3
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30). Change in Individual Scores in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib
    measure definition
    The Global Health Status Score is derived from question 29 and 30 on the EORTC-QLQ-C30 tool. The change in score was assessed between baseline and week 12 in patients treated with advanced GIST treated with avapritinib compared to patients treated with regorafenib. The Global Health Status Score score range is 0 to 100 with a higher score indicating better global health status. A positive change indicates improvement in global health status.
    time frame
    Difference between baseline and week 12 of treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score indicating better
    population note
    Intent-to-Treat Population with both a baseline and a Week 12 measurements.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice