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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05734105
Registration number
NCT05734105
Ethics application status
Date submitted
8/02/2023
Date registered
17/02/2023
Date last updated
31/05/2024
Titles & IDs
Public title
A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
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Scientific title
An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated With Imatinib
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Secondary ID [1]
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DCC-2618-03-003
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Universal Trial Number (UTN)
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Trial acronym
INSIGHT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
GIST
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ripretinib
Treatment: Drugs - Sunitinib
Experimental: Ripretinib - 150 mg QD of ripretinib (3×50 mg tablets) will be dosed continuously in repeated 42-day cycles.
Active Comparator: Sunitinib - 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: Drugs: Ripretinib
50 mg tablets
Treatment: Drugs: Sunitinib
12.5 mg tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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The time from randomization until documented progressive disease (PD) based on IRR per mRECIST or death due to any cause, whichever occurs first.
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Timepoint [1]
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Up to end of treatment; up to approximately 48 months
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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Compare ORR by IRR of ripretinib vs sunitinib using mRECIST
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Timepoint [1]
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Up to end of treatment; up to approximately 48 months
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Compare OS of ripretinib vs sunitinib
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Timepoint [2]
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Up to approximately 48 months
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Eligibility
Key inclusion criteria
1. Male or female =18 years of age.
2. Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed
by ctDNA sample.
3. Participants must have advanced GIST and radiologic progression on imatinib treatment.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of =2 at screening.
5. Female participants of childbearing potential must have a negative pregnancy test at
screening and prior to the first dose of study drug.
6. Participants of reproductive potential must agree to follow contraception
requirements.
7. Participants must have at least 1 measurable lesion according to mRECIST v1.1 within
21 days prior to the first dose of study drug.
8. Adequate organ function and bone marrow reserve based on laboratory assessments
performed at screening.
9. Resolution of all toxicities from prior therapy to Grade =1 (or participant baseline)
within 1 week prior to the first dose of study drug.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a
ctDNA sample.
2. Has known active central nervous system metastases.
3. New York Heart Association Class II-IV heart disease, myocardial infarction within 6
months of Cycle 1 Day 1, active ischemia or any other uncontrolled cardiac condition
such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy,
uncontrolled hypertension, or congestive heart failure.
4. Use of strong or moderate inhibitors or inducers of cytochrome P450 (CYP) 3A prior to
the first dose of study drug, and consumption of grapefruit or grapefruit juice within
14 days prior to the first dose of study drug.
5. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study
drug.
6. Known human immunodeficiency virus or hepatitis C infection only if the participant is
taking medications that are excluded per protocol, acute or chronic hepatitis B, or
acute or chronic hepatitis C infection.
7. Gastrointestinal abnormalities including, but not limited to:
1. inability to take oral medication
2. malabsorption syndromes
3. requirement for intravenous alimentation
8. Any active bleeding excluding hemorrhoidal or gum bleeding.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
54
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
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California
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Connecticut
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Ontario
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Seoul
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Groningen
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Pontevedra
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Greater London
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United Kingdom
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West Yorkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Deciphera Pharmaceuticals LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the
efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line
treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without
KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent
radiologic review, participants randomized to sunitinib will be given the option to either
crossover to receive ripretinib 150 mg QD or discontinue sunitinib.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05734105
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Team
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Address
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Deciphera Pharmaceuticals LLC
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Contact person for public queries
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Clinical Team
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Phone
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785-830-2100
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05734105
Download to PDF