{"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":[["tazemetostat"],["tazemetostat","prednisolone"]],"indication":"relapsed/refractory B-cell lymphomas and advanced solid tumors","name":"E7438-G000-101","nct_id":"NCT01897571","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=e7438-g000-101-nct01897571. 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":"Patients in the Phase 1 portion of the study.","label":"Phase 1","type":"EXPERIMENTAL"},{"description":"Patients with R/R FL with mutant EZH2 treated with tazemetostat as a single agent in Phase 2 of the study.","label":"Phase 2 Group 1: Tazemetostat in R/R FL with Mutant EZH2","type":"EXPERIMENTAL"},{"description":"Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study.","label":"Phase 2 Group 2: Tazemetostat in R/R FL with Wild-Type EZH2","type":"EXPERIMENTAL"},{"description":"Patients with R/R DLBCL treated with tazemetostat as a single agent or tazemetostat in combination with prednisolone in Phase 2 of the study.","label":"Phase 2 Group 3: Tazemetostat in R/R DLBCL","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2021-11-02","type":"ACTUAL"},"conditions":["B-cell Lymphomas (Phase 1)","Advanced Solid Tumors (Phase 1)","Diffuse Large B-cell Lymphoma (Phase 2)","Follicular Lymphoma (Phase 2)","Transformed Follicular Lymphoma","Primary Mediastinal Large B-Cell Lymphoma"],"enrollment":{"count":400,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Tazemetostat","otherNames":["EPZ-6438","E7438"],"type":"DRUG"},{"name":"Prednisolone","otherNames":["Pediapred","Omnipred","Pred Mild","Pred Forte,","Orapred ODT,","Veripred 20,","Millipred DP"],"type":"DRUG"},{"name":"Tazemetostat","otherNames":["EPZ-6438","E7438"],"type":"DRUG"}],"last_update":"2024-03-26","lead_sponsor":"Epizyme, Inc.","official_title":"An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2021-08-24","type":"ACTUAL"},"primary_outcomes":[{"measure":"Recommended Phase 2 Dose (RP2D) of Tazemetostat as a Single-Agent and in Combination With Prednisolone (Phase 1 Only)","timeFrame":"The first 28-day cycle of therapy"},{"measure":"Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR]) (Phase 2)","timeFrame":"Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 8 weeks during Cycles 2 to 6,and then every 12 weeks thereafter until confirmed disease progression (PD)/death,a maximum of approximately 82 months"}],"references":[{"citation":"Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024.","pmid":"39563886","type":"DERIVED"},{"citation":"Bosch F, Kuruvilla J, Vassilakopoulos TP, Maio DD, Wei MC, Zumofen MB, Nastoupil LJ. Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 Feb;24(2):105-121. doi: 10.1016/j.clml.2023.09.007. Epub 2023 Sep 28.","pmid":"37981564","type":"DERIVED"},{"citation":"Morschhauser F, Tilly H, Chaidos A, McKay P, Phillips T, Assouline S, Batlevi CL, Campbell P, Ribrag V, Damaj GL, Dickinson M, Jurczak W, Kazmierczak M, Opat S, Radford J, Schmitt A, Yang J, Whalen J, Agarwal S, Adib D, Salles G. Tazemetostat for patients with relapsed or refractory follicular lymphoma: an open-label, single-arm, multicentre, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1433-1442. doi: 10.1016/S1470-2045(20)30441-1. Epub 2020 Oct 6.","pmid":"33035457","type":"DERIVED"},{"citation":"Italiano A, Soria JC, Toulmonde M, Michot JM, Lucchesi C, Varga A, Coindre JM, Blakemore SJ, Clawson A, Suttle B, McDonald AA, Woodruff M, Ribich S, Hedrick E, Keilhack H, Thomson B, Owa T, Copeland RA, Ho PTC, Ribrag V. Tazemetostat, an EZH2 inhibitor, in relapsed or refractory B-cell non-Hodgkin lymphoma and advanced solid tumours: a first-in-human, open-label, phase 1 study. Lancet Oncol. 2018 May;19(5):649-659. doi: 10.1016/S1470-2045(18)30145-1. Epub 2018 Apr 9.","pmid":"29650362","type":"DERIVED"}],"start_date":{"date":"2013-06-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL","url":"https://clinicaltrials.gov/study/NCT01897571"},"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/e7438-g000-101-nct01897571"}