Trial · NCT03465722
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
NCT03465722, Phase 3, Completed, Blueprint Medicines Corporation; results first posted 2021-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST. Trials, record NCT03465722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03465722
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
- NCT number
- NCT03465722
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 476 participants, actual
- Lead sponsor
- Blueprint Medicines Corporation
- Conditions
- GIST
- Interventions
- avapritinib, regorafenib
- First posted
- 2018-03-14
- Last updated
- 2022-10-06
- Results first posted
- 2021-05-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 24 Months | 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. |
| Secondary | Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1 | 24 Months | 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 |
| Secondary | Overall Survival (OS) in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib | 24 Months | To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib |
| Secondary | 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 | Difference between baseline and week 12 of treatment | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 24 Months | Intent-to-Treat Population that included all patients randomized to study. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1 | 24 Months | Intent-to-Treat Population that included all patients randomized to study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib | 24 Months | months | MEDIAN | |
| SECONDARY | 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 | Difference between baseline and week 12 of treatment | Intent-to-Treat Population with both a baseline and a Week 12 measurements. | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Avapritinib | 4.2 | 95% Confidence Interval 3.7 to 5.6 | months | |
| 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 | Regorafinib | 5.6 | 95% Confidence Interval 3.8 to 7.2 | months | |
| Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1 | Avapritinib | Responder | 41 | Participants | |
| Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1 | Regorafinib | Responder | 17 | Participants | |
| Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1 | Avapritinib | Non-Responder | 199 | Participants | |
| Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1 | Regorafinib | Non-Responder | 219 | Participants | |
| Overall Survival (OS) in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib | Avapritinib | 19.2 | 95% Confidence Interval 19.2 to NA | months | |
| Overall Survival (OS) in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib | Regorafinib | 17.4 | 95% Confidence Interval 15.8 to NA | months | |
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 | Avapritinib | -5.7 | Standard Deviation 24.29 | scores on a scale | |
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 | Regorafinib | -4.4 | Standard Deviation 20.74 | scores on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Avapritinib | 240 | |
| Overall Study | STARTED | Regorafinib | 236 | |
| Overall Study | COMPLETED | Avapritinib | 0 | |
| Overall Study | COMPLETED | Regorafinib | 0 | |
| Overall Study | NOT COMPLETED | Avapritinib | 240 | |
| Overall Study | NOT COMPLETED | Regorafinib | 236 |
Source ClinicalTrials.gov
Adverse events398
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Periorbital oedema | Eye disorders | Avapritinib | 68 | 239 | |
| other | Periorbital oedema | Eye disorders | Regorafinib | 0 | 234 | |
| other | Lacrimation increased | Eye disorders | Avapritinib | 45 | 239 | |
| other | Lacrimation increased | Eye disorders | Regorafinib | 0 | 234 | |
| other | Eyelid oedema | Eye disorders | Avapritinib | 35 | 239 | |
| other | Eyelid oedema | Eye disorders | Regorafinib | 0 | 234 | |
| other | Dyspepsia | Gastrointestinal disorders | Avapritinib | 21 | 239 | |
| other | Dyspepsia | Gastrointestinal disorders | Regorafinib | 16 | 234 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Avapritinib | 16 | 239 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Regorafinib | 7 | 234 |
1 to 10 of 398Source ClinicalTrials.gov
See all 398 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avapritinib | 89 | 239 |
| Total, all-cause mortality | Regorafinib | 87 | 234 |
| Total, other adverse events | Avapritinib | 218 | 239 |
| Total, other adverse events | Regorafinib | 224 | 234 |
| Total, serious adverse events | Avapritinib | 106 | 239 |
| Total, serious adverse events | Regorafinib | 91 | 234 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Avapritinib vs Regorafinib: deaths from any cause | Trial comparisons |
| Avapritinib vs Regorafinib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03465722
GET https://conductscience.org/api/trials/v1/NCT03465722/events?page=2