INSIGHT: A Phase 3 Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

Deciphera Pharmaceuticals LLC (Industry)
Overall Status
Not yet recruiting ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Anticipated Enrollment :
54 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official 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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ripretinib

150 mg QD of ripretinib (3×50 mg tablets) will be dosed continuously in repeated 42-day cycles.

Drug: Ripretinib
50 mg tablets
Other Names:
  • QINLOCK, DCC-2618
  • 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.

    Drug: Sunitinib
    12.5 mg tablets
    Other Names:
  • Sutent
  • Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival (PFS) [Up to end of treatment; up to approximately 48 months]

      The time from randomization until documented progressive disease (PD) based on IRR per mRECIST or death due to any cause, whichever occurs first.

    Secondary Outcome Measures

    1. Objective Response Rate (ORR) [Up to end of treatment; up to approximately 48 months]

      Compare ORR by IRR of ripretinib vs sunitinib using mRECIST

    2. Overall Survival (OS) [Up to approximately 48 months]

      Compare OS of ripretinib vs sunitinib

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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.

    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:

    8. inability to take oral medication

    9. malabsorption syndromes

    10. requirement for intravenous alimentation

    11. Any active bleeding excluding hemorrhoidal or gum bleeding.

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Deciphera Pharmaceuticals LLC


    • Study Director: Clinical Team, Deciphera Pharmaceuticals LLC

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Deciphera Pharmaceuticals LLC Identifier:
    Other Study ID Numbers:
    • DCC-2618-03-003
    First Posted:
    Feb 17, 2023
    Last Update Posted:
    Feb 17, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Deciphera Pharmaceuticals LLC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2023