Trial · NCT03673501
A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
NCT03673501, Phase 3, Active not recruiting, Deciphera Pharmaceuticals, LLC; results first posted 2024-01-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib. Trials, record NCT03673501. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03673501
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
- NCT number
- NCT03673501
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 453 participants, actual
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Conditions
- Gastrointestinal Stromal Tumors
- Interventions
- Ripretinib, Sunitinib
- First posted
- 2018-09-17
- Last updated
- 2026-10-16
- Results first posted
- 2024-01-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population | From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years) | 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. |
| Primary | Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population | From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years) | 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. |
| Secondary | Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population | From confirmed CR or PR to disease progression (up to 1.74 years) | 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. |
| Secondary | Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population | From confirmed CR or PR to disease progression (up to 1.74 years) | 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. |
| Secondary | Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population | From date of randomization until death due to any cause (up to 3.33 years) | OS was defined as the time from the date of randomization until death due to any cause. |
| Secondary | Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population | From date of randomization until death due to any cause (up to 3.33 years) | OS was defined as the time from the date of randomization until death due to any cause. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population | From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years) | 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. | months | MEDIAN |
| PRIMARY | Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population | From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years) | 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. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population | From confirmed CR or PR to disease progression (up to 1.74 years) | 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. | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population | From confirmed CR or PR to disease progression (up to 1.74 years) | 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. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population | From date of randomization until death due to any cause (up to 3.33 years) | 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. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population | From date of randomization until death due to any cause (up to 3.33 years) | 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. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population | Ripretinib | 8.3 | 95% Confidence Interval 6.8 to 13.3 | months | |
| Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population | Sunitinib | 7.0 | 95% Confidence Interval 5.6 to 10.9 | months | |
| Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population | Ripretinib | 8.0 | 95% Confidence Interval 6.5 to 10.8 | months | |
| Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population | Sunitinib | 8.3 | 95% Confidence Interval 6.3 to 11.0 | months | |
| Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population | Ripretinib | 23.9 | 95% Confidence Interval 17.6 to 31.2 | percentage of participants | |
| Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population | Sunitinib | 14.6 | 95% Confidence Interval 9.6 to 21.0 | percentage of participants | |
| Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population | Ripretinib | 21.7 | 95% Confidence Interval 16.5 to 27.6 | percentage of participants | |
| Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population | Sunitinib | 17.6 | 95% Confidence Interval 12.9 to 23.2 | percentage of participants | |
| Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population | Ripretinib | 34.0 | 95% Confidence Interval 29.3 to NA | months | |
| Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population | Sunitinib | 31.5 | 95% Confidence Interval 29.4 to NA | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ripretinib | 226 | |
| Overall Study | STARTED | Sunitinib | 227 | |
| Overall Study | COMPLETED | Ripretinib | 190 | |
| Overall Study | COMPLETED | Sunitinib | 203 | |
| Overall Study | NOT COMPLETED | Ripretinib | 36 | |
| Overall Study | NOT COMPLETED | Sunitinib | 24 |
Source ClinicalTrials.gov
Adverse events346
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 | Anaemia | Blood and lymphatic system disorders | Ripretinib | 25 | 223 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib | 31 | 221 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ripretinib | 2 | 223 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib | 14 | 221 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ripretinib | 0 | 223 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib | 28 | 221 | |
| other | Constipation | Gastrointestinal disorders | Ripretinib | 79 | 223 | |
| other | Constipation | Gastrointestinal disorders | Sunitinib | 48 | 221 | |
| other | Abdominal pain | Gastrointestinal disorders | Ripretinib | 57 | 223 | |
| other | Abdominal pain | Gastrointestinal disorders | Sunitinib | 35 | 221 |
1 to 10 of 346Source ClinicalTrials.gov
See all 346 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ripretinib | 90 | 223 |
| Total, all-cause mortality | Sunitinib | 95 | 221 |
| Total, other adverse events | Ripretinib | 221 | 223 |
| Total, other adverse events | Sunitinib | 219 | 221 |
| Total, serious adverse events | Ripretinib | 64 | 223 |
| Total, serious adverse events | Sunitinib | 61 | 221 |
Source ClinicalTrials.gov
Papers5
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 |
|---|---|
| Ripretinib vs Sunitinib: deaths from any cause | Trial comparisons |
| Ripretinib vs Sunitinib: 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/NCT03673501
GET https://conductscience.org/api/trials/v1/NCT03673501/events?page=2