INSIGHT
Research type
Research Study
Full title
An International, Phase 3, Randomized, Multicenter, Open label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT)
IRAS ID
1007717
Contact name
Priyanka Kamath
Contact email
Sponsor organisation
Deciphera Pharmaceuticals, LLC
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3 study (INSIGHT) to compare the efficacy of ripretinib to sunitinib in participants with Gastrointestinal Stromal Tumor (GIST).
The study will take approximately 20 months to complete and will be performed as a 2-arm, randomized, open-label, global, multicentre study.
Randomized: means that the choice of whether participant will be given ripretinib or sunitinib will be assigned by a computer, by chance, like the flip of a coin.
Open Label: means that participant will know if they are receiving ripretinib or sunitinib.
About 54 people with GIST will be enrolled to participate in the study at approximately 50 sites/medical centres in the UK, US, Canada, Europe, Australia, Asia, and South America
Eligible patients will be randomized in a 2:1 ratio to receive 150 mg QD ripretinib or 50 mg QD sunitinib in 6-week cycles. The key objective of this study is to compare the efficacy of ripretinib versus sunitinib as measured by progression-free survival (PFS) based on independent radiologic review (IRR) in this patient population.
If at any time during the study cancer has worsened (progression based on tumour images of participant) and participant is receiving sunitinib, they may choose to receive ripretinib.
If at any time during the study cancer has worsened and participant is receiving ripretinib or have crossed over to receive ripretinib, they will discontinue ripretinib and their study doctor will coordinate follow up visits and review next treatment options.
Participants will be eligible to receive ripretinib for up to 2 years or until commercially available. This will be extended by agreement between the Sponsor and Investigator for participants who exhibit evidence of clinical benefit, tolerability to ripretinib, and adhere to the study procedures for as long as ripretinib is being developed to support the indication and continuation of treatment does not conflict with the Sponsor’s right to terminate the study.
REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0486
Date of REC Opinion
20 Sep 2023
REC opinion
Further Information Favourable Opinion