{"preliminary_commentary":{"by_channel":{"x_thread":2,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["selitrectinib"]],"indication":"previously treated NTRK fusion-positive solid tumors","name":"NCT03215511","nct_id":"NCT03215511","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03215511. 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":"A Rolling-6 dose escalation design will be used. The starting dose for participants age \\< 12 years will be 25% below the highest dose level cohort divided by 1.73 m\\^2 cleared by the Safety Review Committee (SRC) for subjects age 12 years and older.","label":"Cancer participants <12 years","type":"EXPERIMENTAL"},{"description":"A 3+3 dose escalation design will be used to determine the maximum tolerated dose (MTD)/recommended dose for further study, enrolling 3 to 6 participants per cohort with a starting dose level of 100 mg twice daily (BID).","label":"Cancer participants ≥12 years","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-01-30","type":"ACTUAL"},"conditions":["Solid Tumors Harboring NTRK Fusion"],"enrollment":{"count":81,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Selitrectinib (BAY2731954)","otherNames":["Loxo-195"],"type":"DRUG"}],"last_update":"2024-10-30","lead_sponsor":"Bayer","official_title":"A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2022-04-11","type":"ACTUAL"},"primary_outcomes":[{"measure":"Maximum tolerated dose (MTD)","timeFrame":"Up to 42 days"},{"measure":"Recommended dose","timeFrame":"Up to 12 months"}],"references":[{"citation":"O'Reilly EM, Hechtman JF. Tumour response to TRK inhibition in a patient with pancreatic adenocarcinoma harbouring an NTRK gene fusion. Ann Oncol. 2019 Nov 1;30(Suppl_8):viii36-viii40. doi: 10.1093/annonc/mdz385. Epub 2019 Dec 24.","pmid":"31605106","type":"DERIVED"}],"start_date":{"date":"2017-07-03","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer","url":"https://clinicaltrials.gov/study/NCT03215511"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03215511"}