{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":null,"indication":null,"name":"STARTRK-NG","nct_id":"NCT02650401","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=startrk-ng-nct02650401. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"STARTRK-NG","arms":[{"description":"Arm closed for further enrollment\n\nROS1, ALK non-gene fusion molecular alterations\n\nOral entrectinib (RXDX-101)","label":"Extracranial solid tumors harboring NTRK1/2/3,","type":"ACTIVE_COMPARATOR"},{"description":"Arm closed for further enrollment\n\nmolecular alterations, including gene fusions\n\nOral entrectinib (RXDX-101)","label":"CNS tumors harboring- NTRK1/2/3, ROS1, ALK","type":"ACTIVE_COMPARATOR"},{"description":"Arm closed for further enrollment\n\nOral entrectinib (RXDX-101)","label":"Neuroblastoma","type":"ACTIVE_COMPARATOR"},{"description":"Arm closed for further enrollment\n\nharboring - NTRK1/2/3, ROS1, ALK gene fusions\n\nOral entrectinib (RXDX-101)","label":"Non-neuroblastoma, extracranial solid tumors","type":"ACTIVE_COMPARATOR"},{"description":"Arm closed for further enrollment\n\nAny participant who otherwise meet all other eligibility criteria\n\nOral entrectinib (RXDX-101)","label":"Any participant unable to swallow capsules","type":"ACTIVE_COMPARATOR"},{"description":"gene fusions\n\nOral entrectinib (RXDX-101)","label":"Expansion: CNS tumors harboring NTRK1/2/3, ROS1","type":"ACTIVE_COMPARATOR"},{"description":"NTRK 1,2,3 and ROS1 fusions\n\nOral entrectinib (RXDX-101)","label":"Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-06-30","type":"ESTIMATED"},"conditions":["Solid Tumors","CNS Tumors"],"enrollment":{"count":69,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Entrectinib","otherNames":["RXDX-101"],"type":"DRUG"}],"last_update":"2026-09-23","lead_sponsor":"Hoffmann-La Roche","official_title":"A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-06-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Maximum Tolerated Dose (MTD)","timeFrame":"Approximately 6 months"},{"measure":"Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules","timeFrame":"Approximately 6 months"},{"measure":"Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules","timeFrame":"Approximately 6 months"},{"measure":"Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube)","timeFrame":"Approximately 6 months"},{"measure":"Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules","timeFrame":"Approximately 6 months"},{"measure":"Cohort B: Objective Response Rate (ORR)","timeFrame":"Approximately 6 months"},{"measure":"Cohort D: ORR","timeFrame":"Approximately 6 months"}],"references":[{"citation":"Desai AV, Bagchi A, Armstrong AE, van Tilburg CM, Basu EM, Robinson GW, Wang H, Casanova M, Andre N, Campbell-Hewson Q, Wu Y, Cardenas A, Ci B, Ryklansky C, Devlin CE, Meneses-Lorente G, Wulff J, Hutchinson KE, Gajjar A, Fox E. Efficacy and safety of entrectinib in children with extracranial solid or central nervous system (CNS) tumours harbouring NTRK or ROS1 fusions. Eur J Cancer. 2025 May 2;220:115308. doi: 10.1016/j.ejca.2025.115308. Epub 2025 Feb 22.","pmid":"40086048","type":"DERIVED"},{"citation":"Desai AV, Robinson GW, Gauvain K, Basu EM, Macy ME, Maese L, Whipple NS, Sabnis AJ, Foster JH, Shusterman S, Yoon J, Weiss BD, Abdelbaki MS, Armstrong AE, Cash T, Pratilas CA, Corradini N, Marshall LV, Farid-Kapadia M, Chohan S, Devlin C, Meneses-Lorente G, Cardenas A, Hutchinson KE, Bergthold G, Caron H, Chow Maneval E, Gajjar A, Fox E. Entrectinib in children and young adults with solid or primary CNS tumors harboring NTRK, ROS1, or ALK aberrations (STARTRK-NG). Neuro Oncol. 2022 Oct 3;24(10):1776-1789. doi: 10.1093/neuonc/noac087.","pmid":"35395680","type":"DERIVED"},{"citation":"Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11.","pmid":"31838007","type":"DERIVED"}],"start_date":{"date":"2016-05-03","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options","url":"https://clinicaltrials.gov/study/NCT02650401"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/startrk-ng-nct02650401"}