{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NCT05208047","nct_id":"NCT05208047","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05208047. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"CGT9486 plus sunitinib 37.5 mg QD","label":"Part 1a","type":"EXPERIMENTAL"},{"description":"CGT9486 plus sunitinib 37.5 mg QD","label":"Part 2 - Experimental Group","type":"EXPERIMENTAL"},{"description":"sunitinib 37.5 mg QD","label":"Part 2 - Control Group","type":"ACTIVE_COMPARATOR"},{"description":"CGT9486 plus sunitinib 37.5 mg QD","label":"Part 1b - DDI Cohort 1","type":"EXPERIMENTAL"},{"description":"sunitinib 37.5 mg QD plus CGT9486","label":"Part 1b - DDI Cohort 2","type":"EXPERIMENTAL"},{"description":"Midazolam, CGT9486, sunitinib","label":"DDI Substudy (Midazolam)","type":"EXPERIMENTAL"},{"description":"CGT9486, sunitinib","label":"GIST 1L Substudy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2030-01","type":"ESTIMATED"},"conditions":["Advanced Gastrointestinal Stromal Tumors","Metastatic Cancer"],"enrollment":{"count":482,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"CGT9486","otherNames":["Bezuclastinib"],"type":"DRUG"},{"name":"CGT9486","otherNames":["Bezuclastinib"],"type":"DRUG"},{"name":"Sunitinib","otherNames":[],"type":"DRUG"},{"name":"Sunitinib","otherNames":[],"type":"DRUG"},{"name":"Midazolam","otherNames":[],"type":"DRUG"},{"name":"CGT9486","otherNames":[],"type":"DRUG"},{"name":"Sunitinib","otherNames":[],"type":"DRUG"},{"name":"CGT9486","otherNames":["Bezuclastinib"],"type":"DRUG"},{"name":"Sunitinib","otherNames":[],"type":"DRUG"}],"last_update":"2026-06-16","lead_sponsor":"Cogent Biosciences, Inc.","official_title":"A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2025-09-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part 1a - pharmacokinetics - Cmax","timeFrame":"16 days"},{"measure":"Part 1a - pharmacokinetics - AUC","timeFrame":"16 days"},{"measure":"Part 1b - pharmacokinetics - Cmax","timeFrame":"14 days"},{"measure":"Part 1b - pharmacokinetics - AUC","timeFrame":"14 days"},{"measure":"Part 1b - pharmacokinetics - Tmax","timeFrame":"14 days"},{"measure":"Part 2 - Progression Free Survival (PFS)","timeFrame":"Approximately 48 months"},{"measure":"DDI Substudy - pharmacokinetics - AUC","timeFrame":"16 days"},{"measure":"DDI Substudy - pharmacokinetics - Cmax","timeFrame":"14 days"}],"references":[],"start_date":{"date":"2022-04-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors","url":"https://clinicaltrials.gov/study/NCT05208047"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct05208047"}