{"entity":{"id":"nct03673501","kind":"trial","name":"A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib","aka":["INTRIGUE"],"tldr":"A phase 3 trial of Ripretinib and Sunitinib in gastrointestinal stromal tumour, run by Deciphera Pharmaceuticals, LLC, active and no longer recruiting.","summary":"A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib is a phase 3 interventional study registered as NCT03673501 by Deciphera Pharmaceuticals, LLC, with 453 participants enrolled, started 2019-02-08 and due to reach its primary completion in 2021-09-01. Interventions recorded: Ripretinib and Sunitinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03673501","url":"https://clinicaltrials.gov/study/NCT03673501"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gist","gist-imatinib-resistant"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["ripretinib","sunitinib"],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03673501","phase":"3","setting":"A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib","sponsor":"Deciphera Pharmaceuticals, LLC","started":"2019-02-08","startedType":"actual","yearReported":2024,"enrolled":453,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population","primary":true,"unit":"months","arms":[{"name":"Ripretinib","n":163,"value":8.3,"note":"95% CI 6.8 to 13.3; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication"},{"name":"Sunitinib","n":164,"value":7,"note":"95% CI 5.6 to 10.9"}],"hr":0.88,"ci":[0.66,1.16],"p":"0.3598","source":"https://clinicaltrials.gov/study/NCT03673501?tab=results"},{"endpoint":"Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population","primary":true,"unit":"months","arms":[{"name":"Ripretinib","n":226,"value":8,"note":"95% CI 6.5 to 10.8; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication"},{"name":"Sunitinib","n":227,"value":8.3,"note":"95% CI 6.3 to 11.0"}],"hr":1.05,"ci":[0.82,1.33],"p":"0.7153","source":"https://clinicaltrials.gov/study/NCT03673501?tab=results"},{"endpoint":"Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population","unit":"months","arms":[{"name":"Ripretinib","n":163,"value":34,"note":"95% CI 29.3 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication"},{"name":"Sunitinib","n":164,"value":31.5,"note":"95% CI 29.4 to NA"}],"hr":1.05,"ci":[0.75,1.48],"p":"0.7733","source":"https://clinicaltrials.gov/study/NCT03673501?tab=results"},{"endpoint":"Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population","unit":"%","arms":[{"name":"Ripretinib","n":163,"value":23.9,"note":"95% CI 17.6 to 31.2; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication"},{"name":"Sunitinib","n":164,"value":14.6,"note":"95% CI 9.6 to 21.0"}],"p":"0.0333","source":"https://clinicaltrials.gov/study/NCT03673501?tab=results"}]},"route":"/trials/nct03673501/","neighbours":{"cancer":[{"id":"gist","kind":"cancer","name":"Gastrointestinal stromal tumour (GIST)","route":"/cancers/gist/"},{"id":"gist-imatinib-resistant","kind":"cancer","name":"Imatinib-resistant GIST","route":"/cancers/gist-imatinib-resistant/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"ripretinib","kind":"drug","name":"Ripretinib","route":"/drugs/ripretinib/"},{"id":"sunitinib","kind":"drug","name":"Sunitinib","route":"/drugs/sunitinib/"}],"company":[{"id":"deciphera","kind":"company","name":"Deciphera Pharmaceuticals (Ono)","route":"/companies/deciphera/"}]}}