trialsTrialActive

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

A phase 3 trial of Ripretinib and Sunitinib in gastrointestinal stromal tumour, run by Deciphera Pharmaceuticals, LLC, active and no longer recruiting.

Also called: INTRIGUE

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib is a phase 3 interventional study registered as NCT03673501 by Deciphera Pharmaceuticals, LLC, with 453 participants enrolled, started 2019-02-08 and due to reach its primary completion in 2021-09-01. Interventions recorded: Ripretinib and Sunitinib. Results have been posted on the registry.

Setting

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib

Phase

Phase 3

Sponsor

Deciphera Pharmaceuticals, LLC

Registry

NCT03673501

Started

2019-02-08

Reported

2024

Enrolled

453 enrolled

Outcomes

4top

In plain words

What these results mean for people, not percentages

453 enrolled

Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Populationprimarysurrogate endpoint

Median 8.3 vs 7 months with Ripretinib compared with Sunitinib; about 1.3 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 12 percent lower chance of the event at any given time (hazard ratio 0.88, likely range 0.66 to 1.16).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Populationprimarysurrogate endpoint

Median 8 vs 8.3 months with Ripretinib compared with Sunitinib; about 0.3 months shorter for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 5 percent higher chance of the event at any given time (hazard ratio 1.05, likely range 0.82 to 1.33).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Populationsurvival endpoint

Median 34 vs 31.5 months with Ripretinib compared with Sunitinib; about 2.5 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 5 percent higher chance of the event at any given time (hazard ratio 1.05, likely range 0.75 to 1.48).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Populationresponse endpoint

23.9 vs 14.6 out of 100 had their tumour shrink with Ripretinib compared with Sunitinib; 9.3 more per 100.
Roughly one extra person helped for every 11 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.

The p-value (0.0333) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Caveats

These results apply to the people the trial enrolled: A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

453 enrolled.

Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Populationprimary

HR 0.88 (0.66 to 1.16) · p = 0.3598

Download

95% CI 6.8 to 13.3; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication · 95% CI 5.6 to 10.9

Source

Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Populationprimary

HR 1.05 (0.82 to 1.33) · p = 0.7153

Download

95% CI 6.5 to 10.8; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication · 95% CI 6.3 to 11.0

Source

Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population

HR 1.05 (0.75 to 1.48) · p = 0.7733

Download

95% CI 29.3 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication · 95% CI 29.4 to NA

Source

Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population

· p = 0.0333

Ripretinib23.9 of 100

n = 163

Sunitinib14.6 of 100

n = 164

Download

95% CI 17.6 to 31.2; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication · 95% CI 9.6 to 21.0

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Populationprimary	Ripretinib	163	8.3 months	0.88 (0.66 to 1.16)	0.3598	link
	Sunitinib	164	7 months	0.88 (0.66 to 1.16)	0.3598	link
Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Populationprimary	Ripretinib	226	8 months	1.05 (0.82 to 1.33)	0.7153	link
	Sunitinib	227	8.3 months	1.05 (0.82 to 1.33)	0.7153	link
Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population	Ripretinib	163	34 months	1.05 (0.75 to 1.48)	0.7733	link
	Sunitinib	164	31.5 months	1.05 (0.75 to 1.48)	0.7733	link
Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population	Ripretinib	163	23.9%	-	0.0333	link
	Sunitinib	164	14.6%	-	0.0333	link

Connected

7top

Trial
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Shares Deciphera Pharmaceuticals (Ono), Gastrointestinal stromal tumour (GIST) and the tag pipeline.
Trial
A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
Shares Ripretinib, Deciphera Pharmaceuticals (Ono) and the tag pipeline.
Treatment
NB003
Shares Imatinib-resistant GIST, Gastrointestinal stromal tumour (GIST) and the tag pipeline.
Treatment
IDRX-42
Shares Imatinib-resistant GIST, Gastrointestinal stromal tumour (GIST) and the tag pipeline.
Trial
Savolitinib vs. Sunitinib in MET-driven PRCC.
Shares Sunitinib, Anti-angiogenic therapy, Small-molecule kinase inhibitors and the tag pipeline.
Trial
A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.
Shares Deciphera Pharmaceuticals (Ono) and the tag pipeline.
Trial
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Shares Deciphera Pharmaceuticals (Ono) and the tag pipeline.
Trial
A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies
Shares Anti-angiogenic therapy, Small-molecule kinase inhibitors and the tag pipeline.

cancers

Gastrointestinal stromal tumour (GIST)Imatinib-resistant GIST

technologies

Anti-angiogenic therapy Small-molecule kinase inhibitors

drugs

ApprovedSmall-molecule kinase inhibitor (KIT/PDGFRA switch-control)

Ripretinib · Qinlock

ApprovedSmall-molecule multi-kinase inhibitor (VEGFR, PDGFR, KIT)

Sunitinib · Sutent

companies

Deciphera Pharmaceuticals (Ono)

Evidence strength62/100 · Solid

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
453 enrolled+13
Primary endpoint: time to progression or recurrence+14
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT03673501

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

A phase 3 trial of Ripretinib and Sunitinib in gastrointestinal stromal tumour, run by Deciphera Pharmaceuticals, LLC, active and no longer recruiting.

Also called: INTRIGUE

Setting

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib

Phase

Phase 3

Sponsor

Deciphera Pharmaceuticals, LLC

Registry

NCT03673501

Started

2019-02-08

Reported

2024

Enrolled

453 enrolled

Outcomes

4top

In plain words

What these results mean for people, not percentages

453 enrolled

Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Populationprimarysurrogate endpoint

Median 8.3 vs 7 months with Ripretinib compared with Sunitinib; about 1.3 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 12 percent lower chance of the event at any given time (hazard ratio 0.88, likely range 0.66 to 1.16).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Populationprimarysurrogate endpoint

Median 8 vs 8.3 months with Ripretinib compared with Sunitinib; about 0.3 months shorter for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 5 percent higher chance of the event at any given time (hazard ratio 1.05, likely range 0.82 to 1.33).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Populationsurvival endpoint

Median 34 vs 31.5 months with Ripretinib compared with Sunitinib; about 2.5 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 5 percent higher chance of the event at any given time (hazard ratio 1.05, likely range 0.75 to 1.48).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Populationresponse endpoint

23.9 vs 14.6 out of 100 had their tumour shrink with Ripretinib compared with Sunitinib; 9.3 more per 100.
Roughly one extra person helped for every 11 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.

The p-value (0.0333) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Caveats

These results apply to the people the trial enrolled: A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

453 enrolled.

Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Populationprimary

HR 0.88 (0.66 to 1.16) · p = 0.3598

Download

95% CI 6.8 to 13.3; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication · 95% CI 5.6 to 10.9

Source

Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Populationprimary

HR 1.05 (0.82 to 1.33) · p = 0.7153

Download

95% CI 6.5 to 10.8; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication · 95% CI 6.3 to 11.0

Source

Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population

HR 1.05 (0.75 to 1.48) · p = 0.7733

Download

95% CI 29.3 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication · 95% CI 29.4 to NA

Source

Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population

· p = 0.0333

Ripretinib23.9 of 100

n = 163

Sunitinib14.6 of 100

n = 164

Download

95% CI 17.6 to 31.2; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication · 95% CI 9.6 to 21.0

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Populationprimary	Ripretinib	163	8.3 months	0.88 (0.66 to 1.16)	0.3598	link
	Sunitinib	164	7 months	0.88 (0.66 to 1.16)	0.3598	link
Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Populationprimary	Ripretinib	226	8 months	1.05 (0.82 to 1.33)	0.7153	link
	Sunitinib	227	8.3 months	1.05 (0.82 to 1.33)	0.7153	link
Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population	Ripretinib	163	34 months	1.05 (0.75 to 1.48)	0.7733	link
	Sunitinib	164	31.5 months	1.05 (0.75 to 1.48)	0.7733	link
Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population	Ripretinib	163	23.9%	-	0.0333	link
	Sunitinib	164	14.6%	-	0.0333	link

Connected

7top

Trial
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Shares Deciphera Pharmaceuticals (Ono), Gastrointestinal stromal tumour (GIST) and the tag pipeline.
Trial
A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
Shares Ripretinib, Deciphera Pharmaceuticals (Ono) and the tag pipeline.
Treatment
NB003
Shares Imatinib-resistant GIST, Gastrointestinal stromal tumour (GIST) and the tag pipeline.
Treatment
IDRX-42
Shares Imatinib-resistant GIST, Gastrointestinal stromal tumour (GIST) and the tag pipeline.
Trial
Savolitinib vs. Sunitinib in MET-driven PRCC.
Shares Sunitinib, Anti-angiogenic therapy, Small-molecule kinase inhibitors and the tag pipeline.
Trial
A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.
Shares Deciphera Pharmaceuticals (Ono) and the tag pipeline.
Trial
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Shares Deciphera Pharmaceuticals (Ono) and the tag pipeline.
Trial
A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies
Shares Anti-angiogenic therapy, Small-molecule kinase inhibitors and the tag pipeline.

cancers

Gastrointestinal stromal tumour (GIST)Imatinib-resistant GIST

technologies

Anti-angiogenic therapy Small-molecule kinase inhibitors

drugs

ApprovedSmall-molecule kinase inhibitor (KIT/PDGFRA switch-control)

Ripretinib · Qinlock

ApprovedSmall-molecule multi-kinase inhibitor (VEGFR, PDGFR, KIT)

Sunitinib · Sutent

companies

Deciphera Pharmaceuticals (Ono)

Evidence strength62/100 · Solid

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
453 enrolled+13
Primary endpoint: time to progression or recurrence+14
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT03673501

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

Outcomes

Connected

Similar pages

cancers

technologies

drugs

companies

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

Outcomes

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cancers

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

Overview

Outcomes

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cancers

technologies

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companies

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

Overview

Outcomes

Connected

Similar pages

cancers

technologies

drugs

companies