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RecruitingLast updated: 28 February 2024

INSIGHT: This study is comparing two types of targeted therapy in people with gastrointestinal stromal tumours (GIST) who have progressed on prior treatment with imatinib and have other specific mutationsAn 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

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive 150mg of Ripretinib once daily (as 3 x 50mg oral tablets). Ripretinib will be given continuously in repeated 42-day cycles.

In the Active Comaprator Arm, participants will receive 50mg of Sunitinib once daily (as 4 x 12.5mg capsules). Sunitinib will be given continuously for 4 weeks with a 2-week break.

Conditions

This trial is treating patients with advanced gastrointestinal stromal tumours (GIST) with KIT Exon 11 and co-occurring KIT Exons 17 and/or 18 mutations who were previously treated with Imatinib

Cancer

Sarcoma Cancers Sarcoma

Age

People18+

Phase

III

Trial Acronym

INSIGHT

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Deciphera Pharmaceuticals LLC

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

Eligibility

Inclusion

  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

  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.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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