{"commentary":{"count":5,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":4,"podcast":1},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"SENTRY","nct_id":"NCT04562389","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=sentry-nct04562389. The price is fixed at order. We build the report after 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: 1–12 commentary sources"},"registry":{"acronym":"SENTRY","arms":[{"description":"Participants with MF will receive a dose of 40 milligrams (mg) selinexor oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib twice a day (BID) based on the participants baseline platelet count.","label":"Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID","type":"EXPERIMENTAL"},{"description":"Participants with MF will receive a dose of 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.","label":"Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID","type":"EXPERIMENTAL"},{"description":"Participants with MF will receive a dose of 40 or 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.","label":"Phase 1b: Selinexor and Ruxolitinib BID","type":"EXPERIMENTAL"},{"description":"Participants with MF will receive a fixed starting dose of 60 mg selinexor (RD) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.","label":"Phase 3: Selinexor 60 mg + Ruxolitinib BID","type":"EXPERIMENTAL"},{"description":"Participants with MF will receive a matching placebo of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.","label":"Phase 3: Placebo + Ruxolitinib BID","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2028-03","type":"ESTIMATED"},"conditions":["Myelofibrosis"],"enrollment":{"count":353,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Selinexor","type":"DRUG"},{"name":"Selinexor","type":"DRUG"},{"name":"Placebo","type":"OTHER"},{"name":"Ruxolitinib","type":"DRUG"}],"last_update":"2026-10-01","lead_sponsor":"Karyopharm Therapeutics Inc","official_title":"A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2026-02-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase 3: Proportion of Participants with Spleen Volume Reduction (SVR) of Greater than or Equal to (>=) 35 Percent (%) (SVR35) at Week 24 Measured by the Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan","timeFrame":"At Week 24"},{"measure":"Phase 3: Absolute mean change in TSS (Abs-TSS) from baseline to Week 24 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0","timeFrame":"At Week 24"},{"measure":"Phase 1: Maximum Tolerated Dose (MTD)","timeFrame":"Approximately within the first cycle (28 days) of therapy"},{"measure":"Phase 1: Recommended Phase 2 Dose (RP2D)","timeFrame":"Approximately within the first cycle (28 days) of therapy"},{"measure":"Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity","timeFrame":"From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)"}],"references":[{"citation":"Bose P, Ali H, Al-Ali HK, Garcia-Gutierrez V, Grosicki S, Grudeva-Popova Z, Harrison C, Hong J, Hou HA, Kwiatek M, Loschi M, Passamonti F, Patriarca A, Podoltsev N, Rampal R, Tantravahi S, Urian LG, Chai Y, Taverna P, Mark T, Sadiq A, Rangwala R, Vachhani P, Mascarenhas J; SENTRY Trial Investigators. Selinexor Plus Ruxolitinib in Janus Kinase Inhibitor-Naive Myelofibrosis: Phase III SENTRY Trial. J Clin Oncol. 2026 Aug;44(22):2098-2109. doi: 10.1200/JCO-26-01080. Epub 2026 Jun 2.","pmid":"42227656","type":"DERIVED"},{"citation":"Ali H, Mohan S, Kishtagari A, Prchal JT, Maher K, Chai Y, Gudi G, Taverna P, Mark T, Tantravahi SK. Selinexor plus ruxolitinib in JAK inhibitor-naive patients with myelofibrosis: a multicenter, open-label, phase 1 study. Blood Adv. 2026 May 26;10(10):3383-3397. doi: 10.1182/bloodadvances.2025018706.","pmid":"41785311","type":"DERIVED"},{"citation":"Mascarenhas J, Maher K, Rampal R, Bose P, Podoltsev N, Hong J, Chai Y, Kye S, Method M, Harrison C; SENTRY investigators. Selinexor plus ruxolitinib in JAK inhibitor treatment-naive myelofibrosis: SENTRY Phase 3 study design. Future Oncol. 2025 Mar;21(7):807-813. doi: 10.1080/14796694.2025.2461393. Epub 2025 Feb 6.","pmid":"39911057","type":"DERIVED"}],"start_date":{"date":"2021-03-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis","url":"https://clinicaltrials.gov/study/NCT04562389"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/sentry-nct04562389"}