[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475900":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":730,"collaborators":732,"id":741,"slug":34,"hasResults":742,"nctId":743,"briefTitle":744,"officialTitle":745,"acronym":746,"eligibilityCriteria":747,"healthyVolunteers":742,"sex":748,"minAge":749,"maxAge":34,"enrollmentInfo":750,"targetDuration":34,"studyType":753,"phases":754,"briefSummary":756,"conditions":757,"keywords":761,"overallStatus":56,"whyStopped":34,"lastUpdateSubmitDate":766,"lastUpdatePostDateStruct":767,"startDateStruct":770,"completionDateStruct":772,"leadSponsor":774,"locationsCount":775},{"fullName":5,"class":6},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"everolimus","ACTIVE_COMPARATOR","Tablets of 2.5 mg or 10 mg. The prescribed dose is 5 mg\u002Fm²\u002Fday, orally, once daily. Dose will be capped at 10 mg once daily.\n\nTreatment will be continued until unacceptable toxicity, centrally confirmed tumor progression (either radiologically or histologically) and\u002For withdrawal of patient, parents or legal representative consent.\n\nAt the time of centrally confirmed relapse or progression, patients will stop treatment and will be allowed to switch to the other arm in case no better option is available after considering the results of the molecular profiling. In case of switch (everolimus to ONC201 or vice-versa), the patient will observe a wash-out period of 7 days before starting:\n\n* the second treatment,\n* or a reirradiation (if applicable). No treatment is allowed during reirradiation, except setroids and bevacizumab. Then, if an additional treatment is needed, the second treatment will be started within one week after the end of the reirradiation.",[13,14],"Drug: Everolimus","Radiation: Radiotherapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Dordaviprone (ONC201)","EXPERIMENTAL","Capsules of 125 mg. The prescribed dose is 375 mg\u002Fm², orally, once daily at Day 1 and Day 2 of each week.\n\nDose will be capped at 625 mg per dose.\n\nTreatment will be continued until unacceptable toxicity, centrally confirmed tumor progression (either radiologically or histologically), and\u002For withdrawal of patient, parents or legal representative consent.\n\nAt the time of centrally confirmed relapse or progression, patients will stop treatment and will be allowed to switch to the other arm in case no better option is available after considering the results of the molecular profiling. In case of switch (everolimus to ONC201 or vice-versa), the patient will observe a wash-out period of 7 days before starting:\n\n* the second treatment,\n* or a reirradiation (if applicable). No treatment is allowed during reirradiation, except setroids and bevacizumab. Then, if an additional treatment is needed, the second treatment will be started within one week after the end of the reirradiation.",[20,14],"Drug: ONC201",[22,30,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Everolimus","Tablets of 2.5 mg or 10 mg. The prescribed dose is 5 mg\u002Fm²\u002Fday, orally, once daily. Dose will be capped at 10 mg once daily.",[9],[28,29],"VOTUBIA","AFINITOR",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"ONC201","Capsules of 125mg. The prescribed dose is 375mg\u002Fm², orally, once daily at Day 1 and Day 2 of each week.\n\nDose will be capped at 625 mg per dose.",[16],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"RADIATION","Radiotherapy","All patients will be treated with 30 conventional single daily fractions of 1.8 Gy to a total of 54 Gy over a planned period of 6 weeks. Dose may be increased up to 60 Gy for adult patients with supratentorial ND-DMG. The clinical target volume will include all the areas of abnormality on T2\u002FFLAIR sequences with a 1-cm margin.\n\nRadiotherapy will have to start within a maximum of 4 weeks for DIPG, up to 6 weeks for other DMG H3K28-altered (ND-DMG), after the biopsy or last surgery. The study medication will be started at Day 1 (+3 days max) of radiotherapy. Reirradiation is permitted only at disease progression according to local practice.\n\nIn case of metastatic disease or intramedullary tumors, patients can be included in the study. In this situation, radiotherapy will have to start within a maximum of 4 weeks for DIPG, up to 6 weeks for other DMG H3K28-altered (ND-DMG), after the biopsy or last surgery while targeted treatment will start at the end of the irradiation.",[16,9],[41],{"name":42,"affiliation":5,"role":43},"Jacques GRILL, MD, PhD","STUDY_CHAIR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":34,"email":48},"CONTACT","+33 (0)1 42 11 62 09","jacques.grill@gustaveroussy.fr",{"name":50,"role":46,"phone":51,"phoneExt":34,"email":52},"Anne-Sophie BLANC, PharmD","+33 (0)1 42 11 57 02","annesophie.blanc@gustaveroussy.fr",[54,71,87,102,116,130,144,156,170,184,195,209,223,237,248,262,277,287,301,313,327,341,353,367,381,395,407,422,433,447,458,469,484,498,512,523,538,553,567,582,596,607,622,636,647,661,672,686,701,714],{"facility":55,"status":56,"city":57,"state":34,"zip":58,"country":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Aarhus Universitetshospital Skejby","RECRUITING","Aarhus","8200","Denmark",{"type":61,"coordinates":62},"Point",[63,64],10.21076,56.15674,{"lat":64,"lon":63},[67],{"name":68,"role":46,"phone":69,"phoneExt":34,"email":70},"Torben Stamm MIKKELSEN, MD","0045 53 56 65 13","torbmikk@rm.dk",{"facility":72,"status":56,"city":73,"state":34,"zip":74,"country":59,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Rigshospitalet","Copenhagen","2100",{"type":61,"coordinates":76},[77,78],12.56553,55.67594,{"lat":78,"lon":77},[81,85],{"name":82,"role":46,"phone":83,"phoneExt":34,"email":84},"Karsten NYSOM, MD, PhD","0045 3545 0809","karsten.nysom@regionh.dk",{"name":82,"role":86,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"facility":88,"status":56,"city":89,"state":34,"zip":90,"country":59,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"H.C. Andersen Children's Hospital, Odense Universitetshospital","Odense","5000",{"type":61,"coordinates":92},[93,94],10.38831,55.39594,{"lat":94,"lon":93},[97,101],{"name":98,"role":46,"phone":99,"phoneExt":34,"email":100},"Michael CALLESEN, MD, PhD","0045 23 23 46 51","Michael.callesen@rsyd.dk",{"name":98,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":103,"status":56,"city":104,"state":105,"zip":106,"country":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Gustave Roussy","Villejuif","Val de Marne","94805","France",{"type":61,"coordinates":109},[110,111],2.35992,48.7939,{"lat":111,"lon":110},[114,115],{"name":42,"role":46,"phone":34,"phoneExt":34,"email":48},{"name":42,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":117,"status":56,"city":118,"state":34,"zip":119,"country":107,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"CHU d'Amiens-Picardie Site Sud","Amiens","80054",{"type":61,"coordinates":121},[122,123],2.3,49.9,{"lat":123,"lon":122},[126,129],{"name":127,"role":46,"phone":34,"phoneExt":34,"email":128},"Camille KHANFAR, MD","khanfar.camille@chu-amiens.fr",{"name":127,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":131,"status":56,"city":132,"state":34,"zip":133,"country":107,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Institut de Cancérologie de l'Ouest (ICO) - Site Paul Papin","Angers","49055",{"type":61,"coordinates":135},[136,137],-0.55202,47.47156,{"lat":137,"lon":136},[140,143],{"name":141,"role":46,"phone":34,"phoneExt":34,"email":142},"Paule AUGEREAU, MD","paule.augereau@ico.unicancer.fr",{"name":141,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":145,"status":56,"city":132,"state":34,"zip":146,"country":107,"cosmosGeoPoint":147,"geoPoint":149,"contacts":150},"CHU d'Angers - Bâtiment Robert Debré","49933",{"type":61,"coordinates":148},[136,137],{"lat":137,"lon":136},[151,155],{"name":152,"role":46,"phone":153,"phoneExt":34,"email":154},"Claire BRISSET, MD","+33 (0)2 41 35 38 63","claire.brisset@chu-angers.fr",{"name":152,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":157,"status":56,"city":158,"state":34,"zip":159,"country":107,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"CHU Besançon - Hôpital Jean Minjoz","Besançon","25030",{"type":61,"coordinates":161},[162,163],6.01815,47.24878,{"lat":163,"lon":162},[166,169],{"name":167,"role":46,"phone":34,"phoneExt":34,"email":168},"Véronique LAITHIER, MD","vlaithier@chu-besancon.fr",{"name":167,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":171,"status":56,"city":172,"state":34,"zip":173,"country":107,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"CHU de Bordeaux - Groupe hospitalier Saint André - Hôpital Saint André","Bordeaux","33000",{"type":61,"coordinates":175},[176,177],-0.58046,44.84124,{"lat":177,"lon":176},[180,183],{"name":181,"role":46,"phone":34,"phoneExt":34,"email":182},"Charlotte BRONNIMANN, MD","charlotte.bronnimann@chu-bordeaux.fr",{"name":181,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":185,"status":56,"city":172,"state":34,"zip":186,"country":107,"cosmosGeoPoint":187,"geoPoint":189,"contacts":190},"CHU de Bordeaux - Groupe hospitalier Pellegrin - Hôpital des enfants","33076",{"type":61,"coordinates":188},[176,177],{"lat":177,"lon":176},[191,194],{"name":192,"role":46,"phone":34,"phoneExt":34,"email":193},"Céline ICHER de BOUYN, MD","celine.icher@chu-bordeaux.fr",{"name":192,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":196,"status":56,"city":197,"state":34,"zip":198,"country":107,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"CHRU de Brest - Hôpital Morvan","Brest","29609",{"type":61,"coordinates":200},[201,202],-4.48628,48.39029,{"lat":202,"lon":201},[205,208],{"name":206,"role":46,"phone":34,"phoneExt":34,"email":207},"Liana CARAUSU, MD","liana.carausu@chu-brest.fr",{"name":206,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":210,"status":56,"city":211,"state":34,"zip":212,"country":107,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"CHU de Caen - Hôpital Côte de Nacre","Caen","14033",{"type":61,"coordinates":214},[215,216],-0.35912,49.18585,{"lat":216,"lon":215},[219,222],{"name":220,"role":46,"phone":34,"phoneExt":34,"email":221},"Marianna DEPARIS, MD","deparis-m@chu-caen.fr",{"name":220,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":224,"status":56,"city":225,"state":34,"zip":226,"country":107,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"CHU Estaing","Clermont-Ferrand","63003",{"type":61,"coordinates":228},[229,230],3.08682,45.77969,{"lat":230,"lon":229},[233,236],{"name":234,"role":46,"phone":34,"phoneExt":34,"email":235},"Justyna KANOLD, MD, PhD","jkanold@chu-clermontferrand.fr",{"name":234,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":238,"status":56,"city":225,"state":34,"zip":239,"country":107,"cosmosGeoPoint":240,"geoPoint":242,"contacts":243},"Centre Jean Perrin","63011",{"type":61,"coordinates":241},[229,230],{"lat":230,"lon":229},[244,247],{"name":245,"role":46,"phone":34,"phoneExt":34,"email":246},"Xavier DURANDO, MD, PhD","xavier.durando@clermont.unicancer.fr",{"name":245,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":249,"status":56,"city":250,"state":34,"zip":251,"country":107,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"CHU François Mitterrand","Dijon","21079",{"type":61,"coordinates":253},[254,255],5.01391,47.31344,{"lat":255,"lon":254},[258,261],{"name":259,"role":46,"phone":34,"phoneExt":34,"email":260},"Claire BRIANDET, MD","claire.briandet@chu-dijon.fr",{"name":259,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":263,"status":264,"city":265,"state":34,"zip":266,"country":107,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"CHU Grenoble Alpes - Hôpital Albert Michallon","NOT_YET_RECRUITING","Grenoble","38700",{"type":61,"coordinates":268},[269,270],5.71479,45.17869,{"lat":270,"lon":269},[273,276],{"name":274,"role":46,"phone":34,"phoneExt":34,"email":275},"Caroline PASTERIS, MD","CPasteris@chu-grenoble.fr",{"name":274,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":278,"status":56,"city":265,"state":34,"zip":266,"country":107,"cosmosGeoPoint":279,"geoPoint":281,"contacts":282},"CHU Grenoble Alpes - Hôpital Couple-Enfant",{"type":61,"coordinates":280},[269,270],{"lat":270,"lon":269},[283,286],{"name":284,"role":46,"phone":34,"phoneExt":34,"email":285},"Anne PAGNIER, MD","apagnier@chu-grenoble.fr",{"name":284,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":288,"status":56,"city":289,"state":34,"zip":290,"country":107,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Centre Oscar Lambret","Lille","59020",{"type":61,"coordinates":292},[293,294],3.05512,50.63391,{"lat":294,"lon":293},[297,300],{"name":298,"role":46,"phone":34,"phoneExt":34,"email":299},"Sandra RAIMBAULT, MD","s-raimbault@o-lambret.fr",{"name":298,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":302,"status":264,"city":289,"state":34,"zip":303,"country":107,"cosmosGeoPoint":304,"geoPoint":306,"contacts":307},"Hôpital Roger Salengro","59037",{"type":61,"coordinates":305},[293,294],{"lat":294,"lon":293},[308,312],{"name":309,"role":46,"phone":310,"phoneExt":34,"email":311},"Enora VAULEON, MD","+33 (0)3 21 26 94 52","enora.vauleon@chu-lille.fr",{"name":309,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":314,"status":56,"city":315,"state":34,"zip":316,"country":107,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"Hôpital de la mère et de l'enfant","Limoges","87042",{"type":61,"coordinates":318},[319,320],1.24759,45.83362,{"lat":320,"lon":319},[323,326],{"name":324,"role":46,"phone":34,"phoneExt":34,"email":325},"Christophe PIGUET, MD","Christophe.piguet@chu-limoges.fr",{"name":324,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":328,"status":56,"city":329,"state":34,"zip":330,"country":107,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"Centre Léon Bérard","Lyon","69373",{"type":61,"coordinates":332},[333,334],4.84789,45.74906,{"lat":334,"lon":333},[337,340],{"name":338,"role":46,"phone":34,"phoneExt":34,"email":339},"Pierre LEBLOND, MD, PhD","Pierre.leblond@ihope.fr",{"name":338,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":342,"status":56,"city":329,"state":34,"zip":343,"country":107,"cosmosGeoPoint":344,"geoPoint":346,"contacts":347},"Hôpital Pierre Wertheimer","69500",{"type":61,"coordinates":345},[333,334],{"lat":334,"lon":333},[348,352],{"name":349,"role":46,"phone":350,"phoneExt":34,"email":351},"François DUCRAY, MD, PhD","33 (0)4 72 68 13 21","françois.ducray@chu-lyon.fr",{"name":349,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":354,"status":56,"city":355,"state":34,"zip":356,"country":107,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"Hôpital de La Timone","Marseille","13005",{"type":61,"coordinates":358},[359,360],5.38107,43.29695,{"lat":360,"lon":359},[363,366],{"name":364,"role":46,"phone":34,"phoneExt":34,"email":365},"Nicolas ANDRE, MD, PhD","nicolas.andre@ap-hm.fr",{"name":364,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":368,"status":56,"city":369,"state":34,"zip":370,"country":107,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"Hôpital Arnaud de Villeneuve","Montpellier","34090",{"type":61,"coordinates":372},[373,374],3.87635,43.61093,{"lat":374,"lon":373},[377,380],{"name":378,"role":46,"phone":34,"phoneExt":34,"email":379},"Gilles PALENZUELA, MD","g-palenzuela@chu-montpellier.fr",{"name":378,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":382,"status":56,"city":383,"state":34,"zip":384,"country":107,"cosmosGeoPoint":385,"geoPoint":389,"contacts":390},"CHRU Nancy - Hôpital central","Nancy","54035",{"type":61,"coordinates":386},[387,388],6.18496,48.68439,{"lat":388,"lon":387},[391,394],{"name":392,"role":46,"phone":34,"phoneExt":34,"email":393},"Luc TAILLANDIER, MD, PhD","l.taillandier@chru-nancy.fr",{"name":392,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":396,"status":56,"city":383,"state":34,"zip":397,"country":107,"cosmosGeoPoint":398,"geoPoint":400,"contacts":401},"CHRU Nancy Brabois - Hôpital d'enfants","54500",{"type":61,"coordinates":399},[387,388],{"lat":388,"lon":387},[402,406],{"name":403,"role":46,"phone":404,"phoneExt":34,"email":405},"Marie-Sophie MERLIN, MD","+33 (0)3 83 15 47 34","M.MERLIN@chru-nancy.fr",{"name":403,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":408,"status":56,"city":409,"state":34,"zip":410,"country":107,"cosmosGeoPoint":411,"geoPoint":415,"contacts":416},"CHU de Nice - Hôpital Pasteur 2","Nice","06000",{"type":61,"coordinates":412},[413,414],7.26608,43.70313,{"lat":414,"lon":413},[417,421],{"name":418,"role":46,"phone":419,"phoneExt":34,"email":420},"Véronique BOURG, MD","33 (0)4 92 03 82 80","bourg.v@chu-nice.fr",{"name":418,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":423,"status":56,"city":409,"state":34,"zip":424,"country":107,"cosmosGeoPoint":425,"geoPoint":427,"contacts":428},"CHU de Nice - Hôpital L'Archet 2","06202",{"type":61,"coordinates":426},[413,414],{"lat":414,"lon":413},[429,432],{"name":430,"role":46,"phone":34,"phoneExt":34,"email":431},"Gwenaëlle DUHIL DE BENAZE, MD","duhil-de-benaze.g@chu-nice.fr",{"name":430,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":434,"status":56,"city":435,"state":34,"zip":436,"country":107,"cosmosGeoPoint":437,"geoPoint":441,"contacts":442},"Hôpital Saint Louis","Paris","75010",{"type":61,"coordinates":438},[439,440],2.3488,48.85341,{"lat":440,"lon":439},[443,446],{"name":444,"role":46,"phone":34,"phoneExt":34,"email":445},"Stefania CUZZUBBO, MD","stefania.cuzzubbo@aphp.fr",{"name":444,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":448,"status":56,"city":435,"state":34,"zip":449,"country":107,"cosmosGeoPoint":450,"geoPoint":452,"contacts":453},"Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix","75013",{"type":61,"coordinates":451},[439,440],{"lat":440,"lon":439},[454,457],{"name":455,"role":46,"phone":34,"phoneExt":34,"email":456},"Mehdi TOUAT, MD","mehdi.touat@aphp.fr",{"name":455,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":459,"status":56,"city":435,"state":34,"zip":460,"country":107,"cosmosGeoPoint":461,"geoPoint":463,"contacts":464},"Institut Curie","75248",{"type":61,"coordinates":462},[439,440],{"lat":440,"lon":439},[465,468],{"name":466,"role":46,"phone":34,"phoneExt":34,"email":467},"Franck BOURDEAUT, MD","Franck.bourdeaut@curie.fr",{"name":466,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":470,"status":56,"city":471,"state":34,"zip":472,"country":107,"cosmosGeoPoint":473,"geoPoint":477,"contacts":478},"CHU Poitiers","Poitiers","86021",{"type":61,"coordinates":474},[475,476],0.34348,46.58261,{"lat":476,"lon":475},[479,483],{"name":480,"role":46,"phone":481,"phoneExt":34,"email":482},"Anamaria STETCO, MD","+33 (0)5 49 44 33 02","Anamaria-Ioana.STETCO@chu-poitiers.fr",{"name":480,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":485,"status":56,"city":486,"state":34,"zip":487,"country":107,"cosmosGeoPoint":488,"geoPoint":492,"contacts":493},"CHU de Reims - American Memorial Hospital 2","Reims","51092",{"type":61,"coordinates":489},[490,491],4.02853,49.26526,{"lat":491,"lon":490},[494,497],{"name":495,"role":46,"phone":34,"phoneExt":34,"email":496},"Grégory GUIMARD, MD","gguimard@chu-reims.fr",{"name":495,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":499,"status":56,"city":500,"state":34,"zip":501,"country":107,"cosmosGeoPoint":502,"geoPoint":506,"contacts":507},"Centre Eugène Marquis","Rennes","35042",{"type":61,"coordinates":503},[504,505],-1.67431,48.11109,{"lat":505,"lon":504},[508,511],{"name":509,"role":46,"phone":34,"phoneExt":34,"email":510},"Elodie VAULEON, MD","e.vauleon@rennes.unicancer.fr",{"name":509,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":513,"status":56,"city":500,"state":34,"zip":514,"country":107,"cosmosGeoPoint":515,"geoPoint":517,"contacts":518},"CHU Rennes - Hôpital Sud","35203",{"type":61,"coordinates":516},[504,505],{"lat":505,"lon":504},[519,522],{"name":520,"role":46,"phone":34,"phoneExt":34,"email":521},"Chloé PUISEUX, MD","Chloe.PUISEUX@chu-rennes.fr",{"name":520,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":524,"status":56,"city":525,"state":34,"zip":526,"country":107,"cosmosGeoPoint":527,"geoPoint":531,"contacts":532},"CHU Rouen Normandie - Hôpital Charles-Nicolle","Rouen","76000",{"type":61,"coordinates":528},[529,530],1.09932,49.44313,{"lat":530,"lon":529},[533,536],{"name":534,"role":46,"phone":34,"phoneExt":34,"email":535},"Pascale SCHNEIDER, PhD","Pascale.Schneider@chu-rouen.fr",{"name":537,"role":86,"phone":34,"phoneExt":34,"email":34},"Pascale SCHNEIDER, MD, PhD",{"facility":539,"status":56,"city":540,"state":34,"zip":541,"country":107,"cosmosGeoPoint":542,"geoPoint":546,"contacts":547},"CHU de Saint-Denis de La Réunion","Saint-Denis","97400",{"type":61,"coordinates":543},[544,545],2.35387,48.93564,{"lat":545,"lon":544},[548,552],{"name":549,"role":46,"phone":550,"phoneExt":34,"email":551},"Yves REGUERRE, MD","262 (0)2 62 90 61 10","yves.reguerre@chu-reunion.fr",{"name":549,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":554,"status":56,"city":555,"state":34,"zip":556,"country":107,"cosmosGeoPoint":557,"geoPoint":561,"contacts":562},"CHU de Saint-Etienne - Hôpital Nord","Saint-Etienne","42270",{"type":61,"coordinates":558},[559,560],4.39,45.43389,{"lat":560,"lon":559},[563,566],{"name":564,"role":46,"phone":34,"phoneExt":34,"email":565},"Sandrine THOUVENIN, MD, PhD","sandrine.thouvenin@chu-st-etienne.fr",{"name":564,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":568,"status":264,"city":569,"state":34,"zip":570,"country":107,"cosmosGeoPoint":571,"geoPoint":575,"contacts":576},"CHU de Saint-Pierre de La Réunion Sud","Saint-Pierre","97488",{"type":61,"coordinates":572},[573,574],5.40682,43.29282,{"lat":574,"lon":573},[577,581],{"name":578,"role":46,"phone":579,"phoneExt":34,"email":580},"Mohamed KHETTAB, MD","262 (0) 2 62 35 90 00","mohamed.khettab@chu-reunion.fr",{"name":578,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":583,"status":56,"city":584,"state":34,"zip":585,"country":107,"cosmosGeoPoint":586,"geoPoint":590,"contacts":591},"Centre Régional Lutte Contre le Cancer Paul STRAUSS","Strasbourg","67065",{"type":61,"coordinates":587},[588,589],7.74553,48.58392,{"lat":589,"lon":588},[592,595],{"name":593,"role":46,"phone":34,"phoneExt":34,"email":594},"Roland SCHOTT, MD","r.schott@icans.eu",{"name":593,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":597,"status":56,"city":584,"state":34,"zip":598,"country":107,"cosmosGeoPoint":599,"geoPoint":601,"contacts":602},"Hôpital de Hautepierre","67200",{"type":61,"coordinates":600},[588,589],{"lat":589,"lon":588},[603,606],{"name":604,"role":46,"phone":34,"phoneExt":34,"email":605},"Natacha ENTZ-WERLE, MD, PhD","Natacha.entz-werle@chru-strasbourg.fr",{"name":604,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":608,"status":264,"city":609,"state":34,"zip":610,"country":107,"cosmosGeoPoint":611,"geoPoint":615,"contacts":616},"Hôpital Foch","Suresnes","92150",{"type":61,"coordinates":612},[613,614],2.22929,48.87143,{"lat":614,"lon":613},[617,621],{"name":618,"role":46,"phone":619,"phoneExt":34,"email":620},"Nadia YOUNAN, MD","+33 (0)1 46 25 31 41","n.younan@hopital-foch.com",{"name":618,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":623,"status":56,"city":624,"state":34,"zip":625,"country":107,"cosmosGeoPoint":626,"geoPoint":630,"contacts":631},"Hôpital des enfants","Toulouse","31059",{"type":61,"coordinates":627},[628,629],1.44367,43.60426,{"lat":629,"lon":628},[632,635],{"name":633,"role":46,"phone":34,"phoneExt":34,"email":634},"Anne Isabelle BERTOZZI SALAMON, MD","bertozzi.ai@chu-toulouse.fr",{"name":633,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":637,"status":56,"city":624,"state":34,"zip":625,"country":107,"cosmosGeoPoint":638,"geoPoint":640,"contacts":641},"Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-O) - Institut Claudius Regaud",{"type":61,"coordinates":639},[628,629],{"lat":629,"lon":628},[642,646],{"name":643,"role":46,"phone":644,"phoneExt":34,"email":645},"Delphine LARRIEU-CIRON, MD","33 (0)5 31 15 56 74","LarrieuCiron.Delphine@iuct-oncopole.fr",{"name":643,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":648,"status":56,"city":649,"state":34,"zip":650,"country":107,"cosmosGeoPoint":651,"geoPoint":655,"contacts":656},"CHRU Tours - Hôpital Clocheville","Tours","37000",{"type":61,"coordinates":652},[653,654],0.70398,47.39484,{"lat":654,"lon":653},[657,660],{"name":658,"role":46,"phone":34,"phoneExt":34,"email":659},"Marion GILLIBERT-YVERT, MD","m.gillibert-yvert@chu-tours.fr",{"name":658,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":662,"status":56,"city":649,"state":34,"zip":663,"country":107,"cosmosGeoPoint":664,"geoPoint":666,"contacts":667},"CHRU Tours - Hôpital Bretonneau","37044",{"type":61,"coordinates":665},[653,654],{"lat":654,"lon":653},[668,671],{"name":669,"role":46,"phone":34,"phoneExt":34,"email":670},"Bérangère NARCISO-RAHARIMANANA, MD","b.narciso-raharimanana@chu-tours.fr",{"name":669,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":673,"status":56,"city":674,"state":34,"zip":675,"country":676,"cosmosGeoPoint":677,"geoPoint":681,"contacts":682},"Hospital Vall D´Hebron","Barcelona","8035","Spain",{"type":61,"coordinates":678},[679,680],2.15899,41.38879,{"lat":680,"lon":679},[683],{"name":684,"role":46,"phone":34,"phoneExt":34,"email":685},"Anna LLORT, MD","Anna.llort@vallhebron.cat",{"facility":687,"status":56,"city":688,"state":34,"zip":689,"country":676,"cosmosGeoPoint":690,"geoPoint":694,"contacts":695},"Hospital Universitario Niño Jesus","Madrid","28009",{"type":61,"coordinates":691},[692,693],-3.70256,40.4165,{"lat":693,"lon":692},[696,700],{"name":697,"role":46,"phone":698,"phoneExt":34,"email":699},"Álvaro LASSALETTA, MD","00 34 915 03 59 38","alvaro.lassaletta@salud.madrid.org",{"name":697,"role":86,"phone":34,"phoneExt":34,"email":34},{"facility":702,"status":56,"city":703,"state":34,"zip":704,"country":676,"cosmosGeoPoint":705,"geoPoint":709,"contacts":710},"Hospital Universitario y Politécnico de La Fe","Valencia","46026",{"type":61,"coordinates":706},[707,708],-0.37966,39.47391,{"lat":708,"lon":707},[711],{"name":712,"role":46,"phone":34,"phoneExt":34,"email":713},"Adela CAÑETE NIETO, MD","canyete_ade@gva.es",{"facility":715,"status":56,"city":716,"state":34,"zip":717,"country":718,"cosmosGeoPoint":719,"geoPoint":723,"contacts":724},"Karolinska University Hospital","Stockholm","17176","Sweden",{"type":61,"coordinates":720},[721,722],18.06871,59.32938,{"lat":722,"lon":721},[725,729],{"name":726,"role":46,"phone":727,"phoneExt":34,"email":728},"Klas BLOMGREN, MD, PhD","0046 8 123 747 57","klas.blomgren@regionstockholm.se",{"name":726,"role":86,"phone":34,"phoneExt":34,"email":34},{"type":731,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[733,735,738],{"name":734,"class":6},"Innovative Therapies For Children with Cancer Consortium",{"name":736,"class":737},"Ministry of Health, France","OTHER_GOV",{"name":739,"class":740},"Jazz Pharmaceuticals","INDUSTRY","100475900",false,"NCT05476939","Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0","Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication","BIOMEDE 2","Eligibility criteria for the inclusion (registration) in BIOMEDE 2.0 study:\n\n* Diagnosis Criteria:\n\n  * Diagnosis of DIPG (clinical and radiological). As biopsy is not standard for these tumors, an informed consent is required for the necessary histological verification. \\[Biopsy-part of BIOMEDE 2.0 trial\\]. OR\n  * Histological diagnosis of DIPG (i.e. H3K28M or EZHIP positive Diffuse Midline Glioma located in the pons) in case the tumor biopsy was performed before study entry. The diagnosis will be defined by 1\u002F diffuse glioma, 2\u002F H3K28M mutation or loss of H3K28 trimethylation together with EZHIP overexpression. In this situation, patient will sign the consent after the diagnosis to allow central review and biomarkers assessment thereafter. OR\n  * Molecular diagnosis of DIPG (i.e. H3K28M) in case a liquid biopsy (CSF or blood) was performed before study entry, in a patient who could not undergo a tumor biopsy because it was too dangerous according to the patient's clinical condition. The diagnosis will be defined by 1\u002F DIPG, 2\u002F H3K28M mutation. In this situation, patient will sign the consent after the diagnosis to allow collection of the molecular report. OR\n  * Non-DIPG diffuse midline gliomas (ND-DMG), H3K28M mutant or with H3K28 trimethylation loss together with EZHIP overexpression, will be eligible for the trial after biopsy or surgery. As biopsy and surgery is considered as standard practice for these locations, informed consent for the biopsy will not be necessary. Patient will sign the consent after the diagnosis to allow central review and biomarkers assessment thereafter. OR\n  * Non-DIPG diffuse midline gliomas (ND-DMG) will be eligible for the trial before the biopsy in case the diagnosis is clinically or radiologically suspected. Informed consent for the biopsy and molecular analysis will be necessary. Then, if the central pathology review concludes to a ND-DMG with H3K28M mutant or H3K28 trimethylation loss together with EZHIP overexpression, these patients will be eligible for the treatment part of the trial.\n* Eligible for a biopsy, or biopsy material available for the biomarker assessment.\n* Age \\> 6 months, with no upper age limit. Children between 6 months and 3 years will be discussed on a case by case basis for inclusion in the study for the feasibility of the stereotactic biopsy.\n* Eligible for cerebral or craniospinal radiotherapy.\n* Tumor at diagnosis: no prior chemotherapy for the present cancer; no prior cerebral radiation therapy even for another neoplasm. Surgery is allowed when performed for diagnostic or therapeutic purpose.\n* Metastatic diseases or spinal tumors allowed; in this case, patients would receive craniospinal or spinal radiotherapy and medical treatment (everolimus or ONC201) will be postponed and only started after the end of radiotherapy.\n* Patients must be affiliated to a social security system or beneficiary of the same according to local requirements.\n* Written informed consent from parents\u002Flegal representative, patient, and age-appropriate assent before any study-specific procedures are conducted according to local, regional or national guidelines.\n\nNon eligibility criteria for the inclusion (registration) in BIOMEDE 2.0 study:\n\n* Uncontrolled spontaneous massive intratumor bleeding. Patients with post-operative bleeding will be allowed to enter the study provided the hemorrhage is controled. Same rule applies for the other post-operative complications (infection, CSF leakage, absence of wound closure, subdural collection…).\n* Any other concomitant anti-cancer treatment not foreseen by this protocol is not allowed, except corticosteroids and Bevacizumab which are allowed during the protocol. Bevacizumab is not allowed before and until 15 days after the surgery. The use of bevacizumab and corticosteroids will be taken into account when judging the possibility of progression\u002Fpseudoprogression.\n* Any other cancer diagnosed during the last 5 years.\n* Uncontrolled intercurrent illness or active infection.\n* Any other co-morbid condition that in the investigator's opinion would impair study participation.\n* Unable for medical follow-up (geographic, social or mental reasons).\n* Patient previously treated with irradiation on the brainstem for another neoplasm.\n* Participation in another clinical study with an investigational product while on study treatment.\n* Patient under guardianship or deprived of his\u002Fher liberty by a judicial or administrative decision or incapable of giving his\u002Fher consent.\n\nEligibility criteria for the randomization in BIOMEDE 2.0 study:\n\n* Patient enrolled in the BIOMEDE 2.0 study.\n* Life expectancy \\> 12 weeks after the start of study treatment.\n* Histological diagnosis of DIPG (as per the WHO criteria) confirmed by central pathology review, OR Typical radiology of a DIPG (mandatory central radiological review) as well as the short clinical history (less than three months of pre-existing symptoms) in case of suspected DIPG but no histological confirmation (tumor biopsy performed but not informative), or suspected DIPG with detection of H3K28M mutation in the CSF or blood (ctDNA analysis in the CSF or blood), OR Histological diagnosis of ND-DMG confirmed by central pathology review, with mutation in the histone H3.1, H3.2, H3.3 genes, or loss of H3K28me3 and EZHIP overexpression by immunohistochemistry.\n* Karnofsky performance status scale or Lansky Play Scale \\> 50%. The PS should not take the neurologic deficit per se into account. NB: Children and adults with a worse performance status due to glioma-related motor paresis can be included.\n* Highly effective and appropriate contraception for patients (male and female) of reproductive potential during their entire participation in the study and during 6 months after the end of treatment.\n* Negative pregnancy test (serum beta-HCG or urinary test) evaluated within one week prior randomization in sexually active females of reproductive potential.\n* Absolute neutrophil count \\> 1.0 x 10\\^9\u002Fl, Platelets \\> 100 x 10\\^9\u002Fl.\n* Total bilirubin \\\u003C 1.5 x ULN, AST and ALT\\\u003C 2.5 x ULN.\n* Serum creatinine \\\u003C 1.5 X ULN for age. If serum creatinine \\> 1.5 x ULN, creatinine clearance must be \\> 70 ml\u002Fmin\u002F1.73 m² (as per local practice).\n* Normal coagulation tests within the local reference ranges.\n* Written informed consent from parents\u002Flegal representative, patient, and age-appropriate assent before randomization according to local, regional or national guidelines.\n\nNon Eligibility criteria for the randomization in BIOMEDE 2.0 study:\n\n* Current organ toxicity \\> grade 2 according to the NCI-CTCAE version 5.0, especially cardiovascular or renal disease (including but not limited to: congenital long QT syndrome, nephrotic syndrome, glomerulopathy, uncontrolled high blood pressure despite adequate treatment).\n* Patients with the following cardiac history cannot take ONC201:\n\n  * Prolongation of QT\u002FQTcF interval (QTc interval \\> 480 milliseconds) preferably using Frederica's QT correction formula on two ECGs separated by at least 48 hours.\n  * A history of Torsades de pointes or heart failure, hypokalemia, or family history of prolonged QT Syndrome.\n  * Required concomitant use of medication(s) known to prolong the QT\u002FQTc interval.\n\nIn this case, patients will be treated in the Everolimus arm without randomization (except if contra-indication to Everolimus).\n\n* Pregnant or breastfeeding women.\n* Patients with chronic HBV disease compatible with the trial are not excluded from the study. These patients randomized to everolimus treatment will have regular viral load monitoring throughout the study.\n* Patients taking strong P450 inhibitors or inducers or PgP inhibitors are not excluded from the study but drug concentration of everolimus should be monitored carefully to avoid toxicity. Preferably alternative medications should be considered.\n* Patient with known congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption will not be randomized and will be treated in the ONC201 arm (except if contra-indication to ONC201).\n* Patients with known hypersensitivity to any component of Everolimus (active substance, other rapamycin derivatives or excipients) will not be randomized and will be treated in the ONC201 arm (except if contra-indication to ONC201).\n* Patients with known hypersensitivity to any component of ONC201 (drug product or excipients) will not be randomized and will be treated in the Everolimus arm (except if contra-indication to Everolimus).","ALL","6 Months",{"count":751,"type":752},433,"ESTIMATED","INTERVENTIONAL",[755],"PHASE3","The BIOMEDE 2.0 study is the second stage of the BIOMEDE multi-arm, multistage rolling programme (adaptive platform protocol).\n\nIt is a multicenter, randomized, open-label, controlled phase-3 trial evaluating efficacy of ONC201 in comparison with everolimus (primary objective based on internal comparison) and subsequently to historical controls.\n\nTwo treatment groups will be compared. A switch between treatment groups is allowed after confirmation of the disease progression (real-time central review blinded to the treatment arm allocation). Study treatment will be continued until centrally confirmed disease progression (either radiologically or histologically), unacceptable toxicity or consent withdrawal.\n\nThe final conclusion of the trial will be successful for ONC201, if ONC201 is found significantly superior to everolimus in terms of centrally-reviewed PFS (Progression-free survival) from randomization (internal comparison) either overall, considering ND-DMG and DIPG-patients together, or in the subgroup of ND-DMG patients alone. In other cases, Everolimus will remain the standard arm unless it appears associated with an excess of toxicity compared to ONC201 which could then be discussed as a new standard.",[758,759,760],"Diffuse Intrinsic Pontine Glioma","Diffuse Midline Glioma, H3 K27M-Mutant","Diffuse Midline Glioma, H3K27-altered",[762,763,764,765],"Children","Adolescents","Adults","Newly diagnosed","2026-02-03",{"date":768,"type":769},"2026-02-05","ACTUAL",{"date":771,"type":769},"2022-09-29",{"date":773,"type":752},"2031-09",{"name":5,"class":6},50]