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Kinase Inhibitor

Ripretinib 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

INTRIGUE 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.Check my eligibility
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.See study design
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.

INTRIGUE Trial 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.
Select...
I have a molecular pathology report or can provide a tissue sample for testing.
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My organs and bone marrow are functioning well according to recent tests.
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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 side effects from previous treatments are mild or gone, except for hair loss and some blood test abnormalities.
Select...
My condition worsened on imatinib or I couldn't tolerate it.

INTRIGUE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
ALAT
21%
ASAT
15%
Leucocytose
13%
Liver failure
13%
Hand-foot syndrome
10%
Abdominal pain
8%
Increase GGT
8%
Anorexia
8%
Fever
5%
Arterial hypertension
5%
Encephalopathy
5%
Liver pain
5%
Diarrhea
5%
Phosphatases alcalines
5%
Ascite
5%
Encephalopathia
5%
Hemoglobine
3%
Lumbar pain
3%
Hemoglobin
3%
Prothrombin time
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sunitinib

INTRIGUE 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
~110

Find a Location

Who is running the clinical trial?

Deciphera Pharmaceuticals LLCLead Sponsor
16 Previous Clinical Trials
1,791 Total Patients Enrolled
5 Trials studying Gastrointestinal Stromal Tumors
441 Patients Enrolled for Gastrointestinal Stromal Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to participate in this research study?

"According to the information provided on clinicaltrials.gov, this particular clinical trial is not currently accepting new participants. The study was initially posted on February 11th, 2019 and had its most recent update on January 4th, 2021. However, it's worth noting that there are presently an additional 44 active studies actively seeking eligible individuals for participation."

Answered by AI

At how many different venues is this medical investigation currently accessible?

"Hospital de Basurto in Bilbao, Georgia, Ajou University Hospital in Suwon, Kentucky, and the University of California San Diego Medical Center in La Jolla, Maryland are among the select sites where patients can enroll for this trial. Additionally, there are 120 other locations accepting participants as well."

Answered by AI

What is the level of safety associated with DCC-2618 in individuals?

"Based on our assessment at Power, the safety of DCC-2618 is rated as 3. This rating reflects its participation in a Phase 3 trial, indicating that there exists data supporting both efficacy and multiple rounds of safety testing."

Answered by AI
~74 spots leftby Mar 2025