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Tyrosine Kinase Inhibitor
Ripretinib vs Sunitinib for Gastrointestinal Stromal Tumor (INSIGHT Trial)
Phase 3
Recruiting
Research Sponsored by Deciphera Pharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 48 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial compares a new drug (ripretinib) to an existing one (sunitinib) to treat people with GIST who have progressed on a previous drug. Participants may switch to ripretinib if disease progresses.
Who is the study for?
This trial is for adults over 18 with advanced Gastrointestinal Stromal Tumor (GIST) who have progressed after imatinib treatment and have specific KIT exon mutations. Participants must be in good enough health to perform daily activities, not pregnant, agree to use contraception, and cannot have had major surgery recently or certain heart conditions.
What is being tested?
The study compares the effectiveness of two drugs: Ripretinib and Sunitinib in patients whose GIST has worsened despite initial therapy. It's a global test where people are randomly chosen to receive either drug. If Sunitinib fails, those patients can switch to Ripretinib.
What are the potential side effects?
Possible side effects include tiredness, nausea, skin changes like rashes or blisters, high blood pressure, bleeding issues, liver problems which might show as yellowing skin or eyesight troubles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 48 months
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)
Secondary study objectives
Objective Response Rate (ORR)
Overall Survival (OS)
Side effects data
From 2017 Phase 2 & 3 trial • 78 Patients • NCT0116420231%
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
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
150 mg QD of ripretinib (3×50 mg tablets) will be dosed continuously in repeated 42-day cycles.
Group II: SunitinibActive Control1 Intervention
50 mg QD of sunitinib (4×12.5 mg capsules) will be dosed in 42-day cycles. Sunitinib will be given continuously for 4 weeks with a 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
16 Previous Clinical Trials
1,947 Total Patients Enrolled
Deciphera Pharmaceuticals, LLCLead Sponsor
18 Previous Clinical Trials
2,103 Total Patients Enrolled
Clinical TeamStudy DirectorDeciphera Pharmaceuticals, LLC
4 Previous Clinical Trials
423 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My GIST cancer has worsened despite being on imatinib.My cancer has a KIT mutation in exon 9, 13, or 14.I have cancer that has spread to my brain.I can take care of myself but might not be able to do heavy physical work.I can take pills and do not have issues with absorbing food or need IV feeding.I haven't taken drugs that affect CYP3A or had grapefruit in the last 14 days.I am 18 years old or older.My GIST has specific mutations in KIT exons 11 and either 17 or 18.I have HIV or hepatitis C but am not on excluded medications, or I don't have hepatitis B or C.I have not had major surgery in the last 4 weeks.My recent tests show my organs and bone marrow are working well.I am a woman who can have children and have a negative pregnancy test.I have serious heart issues, including recent heart attack or uncontrolled conditions.My side effects from previous treatments have mostly gone away.
Research Study Groups:
This trial has the following groups:- Group 1: Ripretinib
- Group 2: Sunitinib
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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