[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100271443":3},{"organization":4,"armGroups":7,"interventions":105,"overallOfficials":236,"centralContacts":240,"locations":249,"responsibleParty":518,"collaborators":520,"id":528,"slug":529,"hasResults":530,"nctId":531,"briefTitle":532,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":530,"sex":535,"minAge":109,"maxAge":536,"enrollmentInfo":537,"targetDuration":109,"studyType":540,"phases":541,"briefSummary":544,"conditions":545,"keywords":547,"overallStatus":252,"whyStopped":109,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":562},{"fullName":5,"class":6},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER",[8,16,21,27,33,38,42,48,53,58,63,68,73,78,83,88,93,99],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A. Ribociclib + Topotecan and Temozolomide","EXPERIMENTAL","Topotecan iv QD and temozolomide capsules orally QD Days 1 to 5; Ribociclib capsules or oral solution orally QD from Day 6 to 20 of a 28 day cycle.",[13,14,15],"Drug: Ribociclib","Drug: Topotecan","Drug: Temozolomide",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm B. Ribociclib + Everolimus","Ribociclib capsules or oral solution orally QD for 21 days of each 28 day cycle; Everolimus orodispersible tablets orally QD for 28 days.",[13,20],"Drug: Everolimus",{"label":22,"type":10,"description":23,"interventionNames":24},"ARM C. Adavosertib + Carboplatin","Adavosertib capsules orally BID 3 days on \u002F 4 days off in week 1; Carboplatin iv QD AUC 5 on Day 1 of a 21 day cycle.",[25,26],"Drug: Adavosertib","Drug: Carboplatin",{"label":28,"type":10,"description":29,"interventionNames":30},"Arm D. Olaparib + Irinotecan","Olaparib tablets orally BID on Day 1-10 of a 21 day cycle Irinotecan iv QD on Day 4-8 of a 21 day cycle.",[31,32],"Drug: Olaparib","Drug: Irinotecan",{"label":34,"type":10,"description":35,"interventionNames":36},"Arm E. Vistusertib single agent","Vistusertib tablets orally BID 2 days on\u002F5 days off per week of a 28 day cycle.",[37],"Drug: Vistusertib",{"label":39,"type":10,"description":40,"interventionNames":41},"Arm F. Vistusertib + Topotecan and Temozolomide","Topotecan iv QD and temozolomide capsules orally QD Days 1 to 5; Vistusertib tablets orally BID 3 days on\u002F4 days off per week of a 28 day cycle.",[14,15,37],{"label":43,"type":10,"description":44,"interventionNames":45},"Arm G. Nivolumab + Cyclophosphamide +\u002F- Radiotherapy","Nivolumab iv QD every 2 weeks of a 28 day cycle (Days 1 and 15); Cyclophosphamide tablets or oral solution orally BID, 1 week on\u002F1 week off; Palliative irradiation\u002Fradiofrequency\u002Fcryotherapy starting 2 weeks after the first nivolumab injection.",[46,47],"Drug: Nivolumab","Drug: Cyclophosphamide",{"label":49,"type":10,"description":50,"interventionNames":51},"Arm H. Selumetinib + Vistusertib","Selumetinib capsules twice daily on a continous administration. Vistusertib orally twice daily on an intermittent schedule : 2 days on \u002F 5 days off per week of a 28 day cycle.",[37,52],"Drug: Selumetinib",{"label":54,"type":10,"description":55,"interventionNames":56},"Arm I. Enasidenib","Enasidenib tablets or sprinkle solution orally on a continuous dosing once daily (QD) per 28 day cycle.",[57],"Drug: Enasidenib",{"label":59,"type":10,"description":60,"interventionNames":61},"Arm J. Lirilumab + Nivolumab","Nivolumab iv QD on Day 1 and 15 of a 28 day cycle; Lirilumab iv QD on Day 1 of a 28 day cycle",[46,62],"Drug: Lirilumab",{"label":64,"type":10,"description":65,"interventionNames":66},"Arm K. Fadraciclib (CYC065) + Temozolomide","Fadraciclib iv QD on Day 1 (+\u002F- 15) of a 28 day cycle Temozolomide capsules orally QD on Day 1-5 of a 28 day cycle",[15,67],"Drug: Fadraciclib",{"label":69,"type":10,"description":70,"interventionNames":71},"Arm L. Fadraciclib (CYC065) + Cytarabine","Fadraciclib iv QD on Day 1 (+\u002F- 15) of a 28 day cycle Cytarabine iv or sc on Day 2-5 and Day 8-11 of a 28 day cycle",[67,72],"Drug: Cytarabine",{"label":74,"type":10,"description":75,"interventionNames":76},"Arm M. Ribociclib + Everolimus +\u002F- Dexamethasone","Ribociclib capsules or tablets orally QD on Day 1-21 of a 28 day cycle. Everolimus dispersible tablets orally QD on a continuous dosing per 28 day cycle.\n\nFor patients with leukemia and lymphoma:\n\nDexamethasone orally or iv on Day 1-7 of each 28 day cycle. For patients with ALL, AML and Non-Hodgkin Lymphoma (NHL), Intrathecal chemotherapy will be administered additionally as per standard practice depending on CNS status.",[13,20,77],"Drug: Dexamethasone",{"label":79,"type":10,"description":80,"interventionNames":81},"Arm N. Ceralasertib (AZD6738) + Olaparib","Olaparib tablets orally BID per 28 days Ceralasertib tablets QD or BID per 28 day cycle",[31,82],"Drug: Ceralasertib",{"label":84,"type":10,"description":85,"interventionNames":86},"Arm O. Futibatinib (TAS-120)","Futibatinib tablets orally on a continuous dosing QD per 28 day cycle",[87],"Drug: Futibatinib",{"label":89,"type":10,"description":90,"interventionNames":91},"Arm P. Capmatinib (INC280) + Everolimus","Capmatinib tablets orally on a continuous dosing BID per 28 day cycle. Everolimus dispersible tablets orally QD on a continuous dosing per 28 day cycle.",[20,92],"Drug: Capmatinib",{"label":94,"type":10,"description":95,"interventionNames":96},"Arm Q. Peposertib + Avelumab and Metronomic Temozolomide","Peposertib tablets orally on a continuous dosing BID per 28 day cycle Avelumab IV QD on Day 1 and Day 15 of a 28 day cycle Temozolomide capsules orally QD 5 days\u002Fweek of a 28 day cycle",[15,97,98],"Drug: Avelumab","Drug: Peposertib",{"label":100,"type":10,"description":101,"interventionNames":102},"Arm R. Capivasertib + metronomic Vinorelbine","Capivasertib tablets orally BID on Day 1-4\u002Fweek (4 days on\u002F3 days off, every week) of a 28 day cycle.\n\nVinorelbine soft capsules orally once daily on Day 1, 3 and 5\u002Fweek of a 28 day cycle.",[103,104],"Drug: Capivasertib","Drug: Vinorelbine",[106,114,119,124,130,135,140,145,151,156,161,166,171,176,181,186,192,201,206,211,217,222,225,231],{"type":107,"name":108,"description":109,"armGroupLabels":110,"otherNames":111},"DRUG","Ribociclib",null,[9,17,74],[112,113],"Kisqali","LEE011",{"type":107,"name":115,"description":109,"armGroupLabels":116,"otherNames":117},"Topotecan",[9,39],[118],"Hycamtin",{"type":107,"name":120,"description":109,"armGroupLabels":121,"otherNames":122},"Temozolomide",[9,39,64,94],[123],"Temodar",{"type":107,"name":125,"description":109,"armGroupLabels":126,"otherNames":127},"Everolimus",[17,74,89],[128,129],"Afinitor","votubia",{"type":107,"name":131,"description":109,"armGroupLabels":132,"otherNames":133},"Adavosertib",[22],[134],"AZD1775",{"type":107,"name":136,"description":109,"armGroupLabels":137,"otherNames":138},"Carboplatin",[22],[139],"Paraplatin",{"type":107,"name":141,"description":109,"armGroupLabels":142,"otherNames":143},"Olaparib",[28,79],[144],"Lynparza",{"type":107,"name":146,"description":109,"armGroupLabels":147,"otherNames":148},"Irinotecan",[28],[149,150],"Camptosar","CPT-11",{"type":107,"name":152,"description":109,"armGroupLabels":153,"otherNames":154},"Vistusertib",[34,39,49],[155],"AZD2014",{"type":107,"name":157,"description":109,"armGroupLabels":158,"otherNames":159},"Nivolumab",[43,59],[160],"Opdivo",{"type":107,"name":162,"description":109,"armGroupLabels":163,"otherNames":164},"Cyclophosphamide",[43],[165],"Cytoxan",{"type":107,"name":167,"description":109,"armGroupLabels":168,"otherNames":169},"Selumetinib",[49],[170],"Koselugo",{"type":107,"name":172,"description":109,"armGroupLabels":173,"otherNames":174},"Enasidenib",[54],[175],"Idhifa",{"type":107,"name":177,"description":109,"armGroupLabels":178,"otherNames":179},"Lirilumab",[59],[180],"BMS-986015",{"type":107,"name":182,"description":109,"armGroupLabels":183,"otherNames":184},"Fadraciclib",[64,69],[185],"CYC065",{"type":107,"name":187,"description":109,"armGroupLabels":188,"otherNames":189},"Cytarabine",[69],[190,191],"Arabinosylcytosine","Cytosar-U",{"type":107,"name":193,"description":109,"armGroupLabels":194,"otherNames":195},"Dexamethasone",[74],[196,197,198,199,200],"Decadron","Dexasone","Diodex","Hexadrol","Maxidex",{"type":107,"name":202,"description":109,"armGroupLabels":203,"otherNames":204},"Ceralasertib",[79],[205],"AZD6738",{"type":107,"name":207,"description":109,"armGroupLabels":208,"otherNames":209},"Futibatinib",[84],[210],"Tas-120",{"type":107,"name":212,"description":109,"armGroupLabels":213,"otherNames":214},"Capmatinib",[89],[215,216],"Tabrecta","INC280",{"type":107,"name":218,"description":109,"armGroupLabels":219,"otherNames":220},"Avelumab",[94],[221],"BAVENCIO",{"type":107,"name":223,"description":109,"armGroupLabels":224,"otherNames":109},"Peposertib",[94],{"type":107,"name":226,"description":109,"armGroupLabels":227,"otherNames":228},"Capivasertib",[100],[229,230],"TRUQAP","AZD5363",{"type":107,"name":232,"description":109,"armGroupLabels":233,"otherNames":234},"Vinorelbine",[100],[235],"Navelbine",[237],{"name":238,"affiliation":5,"role":239},"Birgit Geoerger, MD","STUDY_CHAIR",[241,245],{"name":238,"role":242,"phone":243,"phoneExt":109,"email":244},"CONTACT","+33 (0)1 42 11 46 61","birgit.geoerger@gustaveroussy.fr",{"name":246,"role":242,"phone":247,"phoneExt":109,"email":248},"Estelle Jullemier, MS","+33 (0)1 42 11 55 51","Estelle.JULLEMIER@gustaveroussy.fr",[250,268,284,296,308,320,332,344,356,368,377,392,405,417,431,443,455,469,481,493,505],{"facility":251,"status":252,"city":253,"state":109,"zip":254,"country":255,"countryCode":256,"cosmosGeoPoint":257,"geoPoint":262,"contacts":263},"Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":258,"coordinates":259},"Point",[260,261],12.56553,55.67594,{"lat":261,"lon":260},[264],{"name":265,"role":242,"phone":266,"phoneExt":109,"email":267},"Karsten Nyson, MD","+45 35 45 08 09","karsten.nysom@regionh.dk",{"facility":269,"status":252,"city":270,"state":271,"zip":272,"country":273,"countryCode":274,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"Gustave Roussy","Villejuif","Val De Marne","94805","France","FR",{"type":258,"coordinates":276},[277,278],2.35992,48.7939,{"lat":278,"lon":277},[281],{"name":282,"role":283,"phone":109,"phoneExt":109,"email":109},"Pablo Berlanga, MD","PRINCIPAL_INVESTIGATOR",{"facility":285,"status":252,"city":286,"state":109,"zip":287,"country":273,"countryCode":274,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"CHU Angers","Angers","49933",{"type":258,"coordinates":289},[290,291],-0.55202,47.47156,{"lat":291,"lon":290},[294],{"name":295,"role":283,"phone":109,"phoneExt":109,"email":109},"Isabelle Pellier",{"facility":297,"status":252,"city":298,"state":109,"zip":299,"country":273,"countryCode":274,"cosmosGeoPoint":300,"geoPoint":304,"contacts":305},"CHU Pellegrin","Bordeaux","33076",{"type":258,"coordinates":301},[302,303],-0.58046,44.84124,{"lat":303,"lon":302},[306],{"name":307,"role":283,"phone":109,"phoneExt":109,"email":109},"Stephane Ducassou",{"facility":309,"status":252,"city":310,"state":109,"zip":311,"country":273,"countryCode":274,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"Centre Oscar Lambret","Lille","59020",{"type":258,"coordinates":313},[314,315],3.05512,50.63391,{"lat":315,"lon":314},[318],{"name":319,"role":283,"phone":109,"phoneExt":109,"email":109},"Sandra Raimbault",{"facility":321,"status":252,"city":322,"state":109,"zip":323,"country":273,"countryCode":274,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Centre Léon Bérard","Lyon","69373",{"type":258,"coordinates":325},[326,327],4.84789,45.74906,{"lat":327,"lon":326},[330],{"name":331,"role":283,"phone":109,"phoneExt":109,"email":109},"Nadège Corradini",{"facility":333,"status":252,"city":334,"state":109,"zip":335,"country":273,"countryCode":274,"cosmosGeoPoint":336,"geoPoint":340,"contacts":341},"Hôpital de La Timone","Marseille","13385",{"type":258,"coordinates":337},[338,339],5.38107,43.29695,{"lat":339,"lon":338},[342],{"name":343,"role":283,"phone":109,"phoneExt":109,"email":109},"Nicolas André",{"facility":345,"status":252,"city":346,"state":109,"zip":347,"country":273,"countryCode":274,"cosmosGeoPoint":348,"geoPoint":352,"contacts":353},"CHU Nantes","Nantes","44093",{"type":258,"coordinates":349},[350,351],-1.55336,47.21725,{"lat":351,"lon":350},[354],{"name":355,"role":283,"phone":109,"phoneExt":109,"email":109},"Estelle Thebaud",{"facility":357,"status":252,"city":358,"state":109,"zip":359,"country":273,"countryCode":274,"cosmosGeoPoint":360,"geoPoint":364,"contacts":365},"Institut Curie","Paris","75005",{"type":258,"coordinates":361},[362,363],2.3488,48.85341,{"lat":363,"lon":362},[366],{"name":367,"role":283,"phone":109,"phoneExt":109,"email":109},"Isabelle Aerts",{"facility":369,"status":252,"city":358,"state":109,"zip":370,"country":273,"countryCode":274,"cosmosGeoPoint":371,"geoPoint":373,"contacts":374},"Hôpital Armand Trousseau","75012",{"type":258,"coordinates":372},[362,363],{"lat":363,"lon":362},[375],{"name":376,"role":283,"phone":109,"phoneExt":109,"email":109},"Arnaud Petit",{"facility":378,"status":252,"city":379,"state":109,"zip":109,"country":380,"countryCode":381,"cosmosGeoPoint":382,"geoPoint":386,"contacts":387},"Fondazione IRCCS Istituto Nazionale dei Tumori","Milan","Italy","IT",{"type":258,"coordinates":383},[384,385],9.18951,45.46427,{"lat":385,"lon":384},[388],{"name":389,"role":242,"phone":390,"phoneExt":109,"email":391},"Michela Casanova, MD","+39 02 23 90 25 94","Michela.Casanova@istitutotumori.mi.it",{"facility":393,"status":394,"city":395,"state":109,"zip":396,"country":380,"countryCode":381,"cosmosGeoPoint":397,"geoPoint":401,"contacts":402},"Ospedale Infantile Regina Margherita","NOT_YET_RECRUITING","Torino","10126",{"type":258,"coordinates":398},[399,400],11.99138,44.88856,{"lat":400,"lon":399},[403],{"name":404,"role":283,"phone":109,"phoneExt":109,"email":109},"Fagioli",{"facility":406,"status":407,"city":408,"state":109,"zip":409,"country":410,"countryCode":411,"cosmosGeoPoint":412,"geoPoint":416,"contacts":109},"Prinses Maxima Centrum","ACTIVE_NOT_RECRUITING","Utrecht","3584 EA","Netherlands","NL",{"type":258,"coordinates":413},[414,415],5.12222,52.09083,{"lat":415,"lon":414},{"facility":418,"status":252,"city":419,"state":109,"zip":420,"country":421,"countryCode":422,"cosmosGeoPoint":423,"geoPoint":427,"contacts":428},"Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":258,"coordinates":424},[425,426],2.15899,41.38879,{"lat":426,"lon":425},[429],{"name":430,"role":283,"phone":109,"phoneExt":109,"email":109},"Raquel Hladun",{"facility":432,"status":252,"city":433,"state":109,"zip":434,"country":421,"countryCode":422,"cosmosGeoPoint":435,"geoPoint":439,"contacts":440},"Hospital del Nino Jesus","Madrid","28009",{"type":258,"coordinates":436},[437,438],-3.70256,40.4165,{"lat":438,"lon":437},[441],{"name":442,"role":283,"phone":109,"phoneExt":109,"email":109},"Alba Rubio",{"facility":444,"status":252,"city":445,"state":109,"zip":446,"country":421,"countryCode":422,"cosmosGeoPoint":447,"geoPoint":451,"contacts":452},"Hospital Universitario La Fe","Valencia","46026",{"type":258,"coordinates":448},[449,450],-0.37966,39.47391,{"lat":450,"lon":449},[453],{"name":454,"role":283,"phone":109,"phoneExt":109,"email":109},"Adela Cañete",{"facility":456,"status":252,"city":457,"state":109,"zip":458,"country":459,"countryCode":460,"cosmosGeoPoint":461,"geoPoint":465,"contacts":466},"Birmingham Children's Hospital","Birmingham","B4 6NH","United Kingdom","UK",{"type":258,"coordinates":462},[463,464],-1.89983,52.48142,{"lat":464,"lon":463},[467],{"name":468,"role":283,"phone":109,"phoneExt":109,"email":109},"Susanne Gatz",{"facility":470,"status":252,"city":471,"state":109,"zip":472,"country":459,"countryCode":460,"cosmosGeoPoint":473,"geoPoint":477,"contacts":478},"Great Ormond Street Hospital","London","WC1N 3JH",{"type":258,"coordinates":474},[475,476],-0.12574,51.50853,{"lat":476,"lon":475},[479],{"name":480,"role":283,"phone":109,"phoneExt":109,"email":109},"Giuseppe Barone",{"facility":482,"status":252,"city":483,"state":109,"zip":484,"country":459,"countryCode":460,"cosmosGeoPoint":485,"geoPoint":489,"contacts":490},"Royal Manchester Children's Hospital","Manchester","M13 9WL",{"type":258,"coordinates":486},[487,488],-2.23743,53.48095,{"lat":488,"lon":487},[491],{"name":492,"role":283,"phone":109,"phoneExt":109,"email":109},"Guy Makin",{"facility":494,"status":252,"city":495,"state":109,"zip":496,"country":459,"countryCode":460,"cosmosGeoPoint":497,"geoPoint":501,"contacts":502},"Royal Victoria Infirmary","Newcastle","NE1 4LP",{"type":258,"coordinates":498},[499,500],-5.88979,54.21804,{"lat":500,"lon":499},[503],{"name":504,"role":283,"phone":109,"phoneExt":109,"email":109},"Quentin Campbell-Hewson",{"facility":506,"status":252,"city":507,"state":109,"zip":109,"country":459,"countryCode":460,"cosmosGeoPoint":508,"geoPoint":512,"contacts":513},"Pediatric and Adolescent Oncology The Royal Marsden Hospital","Sutton",{"type":258,"coordinates":509},[510,511],-0.2,51.35,{"lat":511,"lon":510},[514],{"name":515,"role":242,"phone":516,"phoneExt":109,"email":517},"Lynley Marshall, MD","+44 208 661 3678","Lynley.Marshall@icr.ac.uk",{"type":519,"investigatorFullName":109,"investigatorTitle":109,"investigatorAffiliation":109,"oldNameTitle":109,"oldOrganization":109},"SPONSOR",[521,524,526],{"name":522,"class":523},"National Cancer Institute, France","OTHER_GOV",{"name":525,"class":6},"Fight Kids Cancer",{"name":527,"class":6},"Fondation ARC","100271443","phase-1-european-proof-of-concept-therapeutic-stratification-trial-of-molecular-anomalies-in-relapsed-or-refractory-tumors-100271443",false,"NCT02813135","European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors","ESMART","Inclusion Criteria:\n\n1. Patients must be diagnosed with a haematologic or solid tumor malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists.\n2. Age \\\u003C 18 years at inclusion; patients 18 years and older may be included after discussion with the sponsor if they have a pediatric recurrent\u002Frefractory malignancy.\n3. Patient must have had advanced molecular profiling (i.e. WES\u002FWGS +\u002F- RNAseq) of their recurrent or refractory tumor i.e. at the time of disease progression\u002Frelapse; exceptionally patients with advanced molecular profiling at diagnosis may be allowed.\n4. Evaluable or measurable disease as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1, RANO criteria for patients with HGG, INRC criteria for patients with NB, Leukemia criteria, etc.).\n5. Patients with relapsed or refractory leukemia are eligible for this study.\n6. Performance status: Karnofsky performance status (for patients \\>12 years of age) or Lansky Play score (for patients ≤12 years of age) ≥ 70%. Patients who are unable to walk because of paralysis or stable neurological disability, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n7. Life expectancy ≥ 3 months\n8. Adequate organ function:\n\n   Hematologic criteria (Leukemia patients are excluded from hematological criteria):\n   * Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FμL(unsupported)\n   * Platelet count ≥ 100,000\u002FμL (unsupported)\n   * Hemoglobin ≥ 8.0 g\u002FdL (transfusion is allowed)\n\n   Cardiac function:\n   * Shortening fraction (SF) \\>29% (\\>35% for children \\\u003C 3 years) and left ventricular ejection fraction (LVEF) ≥50% at baseline, as determined by echocardiography (mandatory only for patients who have received cardiotoxic therapy).\n   * Absence of QTc prolongation (QTc \\> 450 msec on baseline ECG, using the Fridericia correction \\[QTcF formula\\]) or other clinically significant ventricular or atrial arrhythmia.\n\n   Renal and hepatic function:\n   * Serum creatinine ≤ 1.5 x upper limit of normal (ULN) for age\n   * Total bilirubin ≤ 1.5 x ULN\n   * Alanine aminotransferase (ALT)\u002Fserum glutamic pyruvic transaminase (SGPT) ≤ 2,5 x ULN; aspartate aminotransferase (AST)\u002Fserum glutamic oxaloacetic transaminase\u002FSGOT ≤ 2,5 x ULN except in patients with documented tumor involvement of the liver who must have AST\u002FSGOT and ALT\u002FSGPT ≤ 5 x ULN.\n9. Able to comply with scheduled follow-up and with management of toxicity.\n10. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of treatment. Sexually active women of childbearing potential must agree to use acceptable and appropriate contraception during the study and for at least 6 months after the last study treatment administration. Sexually active males patients must agree to use condom during the study and for at least 6 months (7 months for arm J) after the last study treatment administration. Acceptable contraception are defined in CTFG Guidelines \"Recommendations related to contraception and pregnancy testing in clinical trials\"\n11. For all oral medications patients must be able to comfortably swallow capsules (except for those for which an oral solution is available); nasogastric or gastrostomy feeding tube administration is allowed only if indicated.\n12. Written informed consent from parents\u002Flegal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.\n13. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.\n\nExclusion Criteria:\n\n1. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease. Patients on stable doses of corticosteroids for at least 7 days prior to receiving study drug may be included.\n2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).\n3. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality, unstable ischemia,congestive heart failure within 12 months of screening)\n4. Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.\n5. Presence of any ≥ CTCAE grade 2 treatment-related toxicity with the exception of alopecia, ototoxicity or peripheral neuropathy.\n6. Systemic anticancer therapy within 21 days of the first study dose or 5 times its half-life, whichever is less.\n7. Previous myeloablative therapy with autologous hematopoietic stem cell rescue within 8 weeks of the first study drug dose\n8. Allogeneic stem cell transplant within 3 months prior to the first study drug dose. Patients receiving any agent to treat or prevent graft-versus host disease (GVHD) post bone marrow transplant are not eligible for this trial.\n9. Radiotherapy (non-palliative) within 21 days prior to the first dose of drug (or within 6 weeks for therapeutic doses of MIBG or craniospinal irradiation).\n10. Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of the investigational drug is administered.\n11. Currently taking medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes (Refer to Appendix 8).\n12. Currently taking medications that are mainly metabolized by CYP3A4\u002F5, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or the drug transporters Pgp (MDR1), BCRP, OATP1B1, OATP1B3, OCT1 and OCT2 and have a low therapeutic index that cannot be discontinued at least 7 days or 5 x reported elimination half-life prior to start of treatment with any of the investigational drugs and for the duration of the study (Refer to Appendix 9).\n13. Known hypersensitivity to any study drug or component of the formulation.\n14. Pregnant or nursing (lactating) females.\n15. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.","ALL","18 Years",{"count":538,"type":539},472,"ESTIMATED","INTERVENTIONAL",[542,543],"PHASE1","PHASE2","This proof-of-concept platform trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe (Geoerger 2017; Geoerger 2019).\n\nThe aims of the trial are:\n\n1. To determine the recommended phase II dose (RP2D) of a specific anticancer agent and\u002For a relevant combination in a pediatric population, to document its tolerability and\n2. To explore first signals of activity in a molecularly enriched study population.",[546],"Pediatric Cancer",[548,549,550,551,552],"Children","Adolescents","Young adults","Recurrent malignancies","Refractory malignancies","2026-01-15",{"date":555,"type":556},"2026-01-16","ACTUAL",{"date":558,"type":556},"2016-08-03",{"date":560,"type":539},"2031-02",{"name":5,"class":6},21]