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Kinase Inhibitor

Ripretinib vs Sunitinib for Gastrointestinal Stromal Tumors (INTRIGUE Trial)

Phase 3
Waitlist Available
Research Sponsored by Deciphera Pharmaceuticals, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have at least 1 measurable lesion according to mRECIST Version 1.1 (non nodal lesions must be ≥ 1.0 cm in the long axis or ≥ double the slice thickness in the long axis) within 21 days prior to the first dose of study drug.
Patients ≥ 18 years of age at the time of informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until death due to any cause (up to 3.33 years)
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is comparing the effectiveness of ripretinib to sunitinib in patients with gastrointestinal stromal tumors (GIST) who did not respond well to their first treatment with imatin

Who is the study for?
This trial is for adults over 18 with Gastrointestinal Stromal Tumors (GIST) who've had issues with the first-line treatment, imatinib. They need a confirmed diagnosis and must provide tissue samples for testing. Participants should be relatively fit (ECOG PS ≤2), not pregnant, willing to use contraception, have at least one measurable tumor lesion, and stable organ function.
What is being tested?
The study compares two drugs: Ripretinib taken daily in continuous 6-week cycles versus Sunitinib taken daily for 4 weeks on/2 weeks off in similar cycles. It's designed to see which drug works better after imatinib fails in advanced GIST patients.
What are the potential side effects?
Potential side effects of Ripretinib and Sunitinib may include fatigue, nausea, diarrhea, high blood pressure, skin changes or rashes, mouth sores, muscle pain or weakness. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be measured by scans.
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I am 18 years old or older.
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I have a GIST diagnosis and can provide a past or new tumor sample.
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I have a molecular pathology report or can provide a tissue sample for testing.
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I can take care of myself and am up and about more than half of my waking hours.
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I am not pregnant, confirmed by two tests before starting the study drug.
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My condition worsened on imatinib or I couldn't tolerate it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until death due to any cause (up to 3.33 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until death due to any cause (up to 3.33 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population
Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population
Secondary study objectives
Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population
Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population
Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population
+1 more

Side effects data

From 2017 Phase 2 & 3 trial • 78 Patients • NCT01164202
31%
Platelets
28%
Neutrophiles
26%
Bilirubine
23%
Asthenia
21%
ASAT
21%
ALAT
15%
Leucocytose
13%
Hand-foot syndrome
13%
Liver failure
10%
Abdominal pain
8%
Fever
8%
Increase GGT
8%
Anorexia
5%
Liver pain
5%
Encephalopathy
5%
Arterial hypertension
5%
Ascite
5%
Diarrhea
5%
Phosphatases alcalines
5%
Encephalopathia
5%
Hemoglobine
3%
Lumbar pain
3%
Hemoglobin
3%
Prothrombin time
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sunitinib

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RipretinibExperimental Treatment1 Intervention
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Group II: SunitinibActive Control1 Intervention
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ripretinib
2020
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Deciphera Pharmaceuticals, LLCLead Sponsor
18 Previous Clinical Trials
1,704 Total Patients Enrolled
Deciphera Pharmaceuticals LLCLead Sponsor
16 Previous Clinical Trials
1,548 Total Patients Enrolled
~67 spots leftby Nov 2025
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