INSIGHT: Ripretinib vs Sunitinib in advanced GIST with specific KIT Exon mutations

 

Trial name: INSIGHT
Agents: Ripretinib vs. Sunitinib
Phase III
Status Recruiting
Sponsor Deciphera Pharmaceuticals

 

This is a Phase 3 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.

Further information can be found on clinicaltrials.gov.

 

WHO is the trial for?
  • Adult patients with confirmed diagnosis of unresectable or metastatic GIST with KIT exon 11 and KIT exon 17 or 18
  • Patients that have progressed under previous therapy with imatinib
  • Overall health status of the patient has to be good (ECOG performance status ≤2)

Excluded are patients with KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations.

WHAT is the key question that this trial is attempting to answer?

 The study compares the efficacy of ripretinib to sunitinib in patients with GIST who progressed on first-line treatment with imatinib. Study participants must have a combination of KIT exons 11+17/18 mutations.

Patients who progress on sunitinib can cross-over to the ripretininb arm.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in GIST and potentially help other patients with this disease. The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 The study is open for recruitment.

WHERE is the trial available?

 The trial is currently active in Australia, Brazil, Canada, Italy, the Netherlands, Spain, Taiwan and the US. Further sites are planned to open soon.

Please check for current information here.

Study contact:

  • Clinical Team
  • Phone Number: +1 785-830-2100
  • Email: Clinicaltrials@deciphera.com

STUDY DESIGN: What does the study look like?

 This trial has two study arms: all participating patients will be randomly divided (by a computer) in two groups.

One group - two thirds of all study participants - receives ripretinib (Arm 1), the second group - one third of all study participants - will be treated with sunitinib (Arm 2).

Patients who progress on sunitinib can cross-over to the ripretininb arm.

HOW do I get more information?

 Patient organizations supporting GIST and/or sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations serving GIST and/or sarcoma patients. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken