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

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ClinicalTrials.gov Identifier: NCT05734105
Recruitment Status : Recruiting
First Posted : February 17, 2023
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
GIST Drug: Ripretinib Drug: Sunitinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 13, 2023
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Sutent


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 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) [ Time Frame: Up to end of treatment; up to approximately 48 months ]
    Compare ORR by IRR of ripretinib vs sunitinib using mRECIST

  2. Overall Survival (OS) [ Time Frame: Up to approximately 48 months ]
    Compare OS of ripretinib vs sunitinib


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. inability to take oral medication
    2. malabsorption syndromes
    3. requirement for intravenous alimentation
  8. Any active bleeding excluding hemorrhoidal or gum bleeding.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05734105


Contacts
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Contact: Clinical Team 785-830-2100 Clinicaltrials@deciphera.com

Locations
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Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
Investigators
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Study Director: Clinical Team Deciphera Pharmaceuticals LLC
More Information
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Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT05734105    
Other Study ID Numbers: DCC-2618-03-003
First Posted: February 17, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deciphera Pharmaceuticals LLC:
advanced gastrointestinal tumors
gastrointestinal stromal tumors
imatinib
ripretinib
Additional relevant MeSH terms:
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Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
 Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action