[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100351032":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":52,"centralContacts":42,"locations":56,"responsibleParty":307,"collaborators":42,"id":309,"slug":310,"hasResults":311,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":42,"eligibilityCriteria":315,"healthyVolunteers":316,"sex":317,"minAge":318,"maxAge":42,"enrollmentInfo":319,"targetDuration":42,"studyType":322,"phases":323,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":331,"whyStopped":332,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":341},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,17,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose-Escalation Phase","EXPERIMENTAL","Participants with newly diagnosed, previously untreated, favorable or intermediate risk AML (according to European LeukemiaNet \\[ELN\\] 2017 criteria) will undergo the treatment sequence of induction, consolidation, and maintenance. For induction, participants will be treated with idasanutlin plus cytarabine and daunorubicin. At the investigator's discretion for consolidation, either participants will be treated with idasanutlin and cytarabine or they will undergo Allo-HSCT. For maintenance, participants will be treated with single-agent idasanutlin.",[13,14,15,16],"Drug: Idasanutlin","Drug: Cytarabine","Drug: Daunorubicin","Procedure: Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)",{"label":18,"type":10,"description":19,"interventionNames":20},"Post-Consolidation Phase","Participants who are idasanutlin treatment-naive, had received induction and chemotherapy consolidation for AML outside of the study, and were in minimal residual disease (MRD)-positive remission after induction will be enrolled in this cohort to receive maintenance treatment with single-agent idasanutlin.",[13],{"label":22,"type":10,"description":23,"interventionNames":24},"Expansion Phase: Favorable\u002FIntermediate-Risk AML","Participants with newly diagnosed, previously untreated, favorable or intermediate risk AML (according to ELN 2017 criteria) will undergo the treatment sequence of induction, consolidation, and maintenance. For induction, participants will be treated with idasanutlin (at the recommended Phase 2 dose) plus cytarabine and daunorubicin. At the investigator's discretion for consolidation, either participants will be treated with idasanutlin and cytarabine or they will undergo Allo-HSCT. For maintenance, participants will be treated with single-agent idasanutlin.",[13,14,15,16],{"label":26,"type":10,"description":27,"interventionNames":28},"Expansion Phase: High-Risk AML","Participants with newly diagnosed, previously untreated, high-risk AML (defined as adverse risk according to ELN 2017 criteria, and secondary AML) will undergo the treatment sequence of induction, consolidation, and maintenance. For induction, participants will be treated with idasanutlin (at the recommended Phase 2 dose) plus cytarabine and daunorubicin. At the investigator's discretion for consolidation, either participants will be treated with idasanutlin and cytarabine or they will undergo Allo-HSCT. For maintenance, participants will be treated with single-agent idasanutlin.",[13,14,15,16],[30,38,43,47],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Idasanutlin","Participants will self-administer idasanutlin tablets by mouth (PO) once daily (QD) for 5 days of each 28-day treatment cycle for up to 2 cycles of induction, up to 4 cycles of consolidation, and 12 cycles of maintenance, according to the study's protocol.",[9,22,26,18],[36,37],"RO5503781","RG7388",{"type":31,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Cytarabine","Cytarabine will be administered for 7 days of each 28-day cycle for up to 2 cycles of induction treatment at a dose of 200 milligrams per meter squared (mg\u002Fm\\^2) of body surface area, once daily (QD) by intravenous (IV) infusion. At the investigator's discretion, cytarabine will also be administered as part of chemotherapy consolidation at a dose of 1.5 g\u002Fm\\^2 QD as IV infusion for 5 days of each 28-day cycle and for up to 4 cycles of treatment.",[9,22,26],null,{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Daunorubicin","Daunorubicin will be administered for 3 days of each 28-day cycle for up to 2 cycles of induction treatment at a dose of 60 mg\u002Fm\\^2 QD as IV infusion.",[9,22,26],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":42},"PROCEDURE","Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)","After induction treatment, participants who achieve remission will either receive chemotherapy consolidation treatment or undergo Allo-HSCT (as per local guidelines) at the investigator's discretion.",[9,22,26],[53],{"name":54,"affiliation":5,"role":55},"Clinical Trials","STUDY_DIRECTOR",[57,70,80,90,100,110,120,130,138,148,158,168,178,185,195,206,215,224,233,242,254,264,275,281,290,299],{"facility":58,"status":42,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":42},"UCLA Jonsson Comprehensive Cancer Center","Los Angeles","California","90095","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-118.24368,34.05223,{"lat":68,"lon":67},{"facility":71,"status":42,"city":72,"state":73,"zip":74,"country":62,"countryCode":63,"cosmosGeoPoint":75,"geoPoint":79,"contacts":42},"Sarah Cannon Research Institute at HealthONE","Denver","Colorado","80218",{"type":65,"coordinates":76},[77,78],-104.9847,39.73915,{"lat":78,"lon":77},{"facility":81,"status":42,"city":82,"state":83,"zip":84,"country":62,"countryCode":63,"cosmosGeoPoint":85,"geoPoint":89,"contacts":42},"Robert H. Lurie Comprehensive Cancer Center of Northwestern University","Chicago","Illinois","60637-1447",{"type":65,"coordinates":86},[87,88],-87.65005,41.85003,{"lat":88,"lon":87},{"facility":91,"status":42,"city":92,"state":93,"zip":94,"country":62,"countryCode":63,"cosmosGeoPoint":95,"geoPoint":99,"contacts":42},"University of Iowa Hospitals and Clinics; Investigational Drug Services","Iowa City","Iowa","52242",{"type":65,"coordinates":96},[97,98],-91.53017,41.66113,{"lat":98,"lon":97},{"facility":101,"status":42,"city":102,"state":103,"zip":104,"country":62,"countryCode":63,"cosmosGeoPoint":105,"geoPoint":109,"contacts":42},"University of Kansas Clinical Research Center; Clinical Trials Office","Fairway","Kansas","66205",{"type":65,"coordinates":106},[107,108],-94.6319,39.02223,{"lat":108,"lon":107},{"facility":111,"status":42,"city":112,"state":113,"zip":114,"country":62,"countryCode":63,"cosmosGeoPoint":115,"geoPoint":119,"contacts":42},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":65,"coordinates":116},[117,118],-71.05977,42.35843,{"lat":118,"lon":117},{"facility":121,"status":42,"city":122,"state":123,"zip":124,"country":62,"countryCode":63,"cosmosGeoPoint":125,"geoPoint":129,"contacts":42},"State University of NY","Brooklyn","New York","11203",{"type":65,"coordinates":126},[127,128],-73.94958,40.6501,{"lat":128,"lon":127},{"facility":131,"status":42,"city":123,"state":123,"zip":132,"country":62,"countryCode":63,"cosmosGeoPoint":133,"geoPoint":137,"contacts":42},"Icahn School of Medicine at Mount Sinai","10029",{"type":65,"coordinates":134},[135,136],-74.00597,40.71427,{"lat":136,"lon":135},{"facility":139,"status":42,"city":140,"state":141,"zip":142,"country":62,"countryCode":63,"cosmosGeoPoint":143,"geoPoint":147,"contacts":42},"Wake Forest Baptist Medical Center","Winston-Salem","North Carolina","27157",{"type":65,"coordinates":144},[145,146],-80.24422,36.09986,{"lat":146,"lon":145},{"facility":149,"status":42,"city":150,"state":151,"zip":152,"country":62,"countryCode":63,"cosmosGeoPoint":153,"geoPoint":157,"contacts":42},"The Ohio State University Comprehensive Cancer Center","Columbus","Ohio","43210",{"type":65,"coordinates":154},[155,156],-82.99879,39.96118,{"lat":156,"lon":155},{"facility":159,"status":42,"city":160,"state":161,"zip":162,"country":62,"countryCode":63,"cosmosGeoPoint":163,"geoPoint":167,"contacts":42},"Thomas Jefferson University Hospital","Philadelphia","Pennsylvania","19107",{"type":65,"coordinates":164},[165,166],-75.16362,39.95238,{"lat":166,"lon":165},{"facility":169,"status":42,"city":170,"state":171,"zip":172,"country":62,"countryCode":63,"cosmosGeoPoint":173,"geoPoint":177,"contacts":42},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030-4009",{"type":65,"coordinates":174},[175,176],-95.36327,29.76328,{"lat":176,"lon":175},{"facility":179,"status":42,"city":180,"state":181,"zip":182,"country":183,"countryCode":184,"cosmosGeoPoint":42,"geoPoint":42,"contacts":42},"The Alfred Hospital","Prahan","Victoria","3181","Australia","AU",{"facility":186,"status":42,"city":187,"state":188,"zip":189,"country":183,"countryCode":184,"cosmosGeoPoint":190,"geoPoint":194,"contacts":42},"Royal Perth Hospital","Perth","Western Australia","6000",{"type":65,"coordinates":191},[192,193],115.8614,-31.95224,{"lat":193,"lon":192},{"facility":196,"status":42,"city":197,"state":42,"zip":198,"country":199,"countryCode":200,"cosmosGeoPoint":201,"geoPoint":205,"contacts":42},"Centre Léon Bérard","Lyon","69008","France","FR",{"type":65,"coordinates":202},[203,204],4.84789,45.74906,{"lat":204,"lon":203},{"facility":207,"status":42,"city":208,"state":42,"zip":209,"country":199,"countryCode":200,"cosmosGeoPoint":210,"geoPoint":214,"contacts":42},"Institut Paoli Calmettes","Marseille","13009",{"type":65,"coordinates":211},[212,213],5.38107,43.29695,{"lat":213,"lon":212},{"facility":216,"status":42,"city":217,"state":42,"zip":218,"country":199,"countryCode":200,"cosmosGeoPoint":219,"geoPoint":223,"contacts":42},"CHU de Nantes - Hotel Dieu","Nantes","44093",{"type":65,"coordinates":220},[221,222],-1.55336,47.21725,{"lat":222,"lon":221},{"facility":225,"status":42,"city":226,"state":42,"zip":227,"country":199,"countryCode":200,"cosmosGeoPoint":228,"geoPoint":232,"contacts":42},"Hôpital Saint-Louis","Paris","75475",{"type":65,"coordinates":229},[230,231],2.3488,48.85341,{"lat":231,"lon":230},{"facility":234,"status":42,"city":235,"state":42,"zip":236,"country":199,"countryCode":200,"cosmosGeoPoint":237,"geoPoint":241,"contacts":42},"Institut Universitaire du Cancer de Toulouse-Oncopole","Toulouse","31059",{"type":65,"coordinates":238},[239,240],1.44367,43.60426,{"lat":240,"lon":239},{"facility":243,"status":42,"city":244,"state":245,"zip":246,"country":247,"countryCode":248,"cosmosGeoPoint":249,"geoPoint":253,"contacts":42},"Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia","Meldola","Emilia-Romagna","47014","Italy","IT",{"type":65,"coordinates":250},[251,252],12.0626,44.12775,{"lat":252,"lon":251},{"facility":255,"status":42,"city":256,"state":257,"zip":258,"country":247,"countryCode":248,"cosmosGeoPoint":259,"geoPoint":263,"contacts":42},"ASST Papa Giovanni XXIII; Dipartimento Interaziendale di Farmacia Clinica","Bergamo","Lombardy","24127",{"type":65,"coordinates":260},[261,262],9.66721,45.69601,{"lat":262,"lon":261},{"facility":265,"status":42,"city":266,"state":42,"zip":267,"country":268,"countryCode":269,"cosmosGeoPoint":270,"geoPoint":274,"contacts":42},"Hospital de la Santa Creu i Sant Pau","Barcelona","08025","Spain","ES",{"type":65,"coordinates":271},[272,273],2.15899,41.38879,{"lat":273,"lon":272},{"facility":276,"status":42,"city":266,"state":42,"zip":277,"country":268,"countryCode":269,"cosmosGeoPoint":278,"geoPoint":280,"contacts":42},"Hospital Universitario Vall d'Hebron","08035",{"type":65,"coordinates":279},[272,273],{"lat":273,"lon":272},{"facility":282,"status":42,"city":283,"state":42,"zip":284,"country":268,"countryCode":269,"cosmosGeoPoint":285,"geoPoint":289,"contacts":42},"Hospital Universitario Fundacion Jimenez Diaz.","Madrid","28040",{"type":65,"coordinates":286},[287,288],-3.70256,40.4165,{"lat":288,"lon":287},{"facility":291,"status":42,"city":292,"state":42,"zip":293,"country":268,"countryCode":269,"cosmosGeoPoint":294,"geoPoint":298,"contacts":42},"Hospital Universitario Virgen del Rocío; Servicio de Neuropediatra","Seville","41013",{"type":65,"coordinates":295},[296,297],-5.97317,37.38283,{"lat":297,"lon":296},{"facility":300,"status":42,"city":301,"state":42,"zip":42,"country":268,"countryCode":269,"cosmosGeoPoint":302,"geoPoint":306,"contacts":42},"Hospital Universitari i Politècnic La Fe","Valencia",{"type":65,"coordinates":303},[304,305],-0.37966,39.47391,{"lat":305,"lon":304},{"type":308,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100351032","phase-1-a-study-evaluating-the-safety-and-efficacy-of-idasanutlin-in-combination-with-cytarabine-and-daunorubicin-in-patients-newly-diagnosed-with-acute-myeloid-leukemia-aml-and-the-safety-and-efficacy-of-idasanutlin-in-the-maintenance-of-first-aml-complete-remission-100351032",true,"NCT03850535","A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission","A Phase Ib\u002FII Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission","Inclusion Criteria:\n\nInclusion Criteria for All Study Phases:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Adequate hepatic and renal function\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs with a failure rate of \\\u003C1% per year during the treatment period and for at least 6 months after the final dose of idasanutlin, cytarabine, or daunorubicin. Women must refrain from donating eggs during this same period.\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive, measures, and agreement to refrain from donating sperm that together result in a failure rate of \\\u003C1% per year during the treatment period and for 6 months after the final dose of idasanutlin, cytarabine, or daunorubicin. Men must refrain from donating sperm during this same period.\n\nInclusion Criteria for Patients in the Dose-Escalation and Expansion Phases:\n\n\\- Documented\u002Fconfirmed newly diagnosed acute myeloid leukemia (AML) not previously treated according to World Health Organization (WHO)\n\nInclusion Criteria for Patients in the Post-Consolidation Phase:\n\n\\- Documented\u002Fconfirmed AML according to WHO in remission after induction, within 21 days of end of last chemotherapy consolidation cycle, and were minimum residual disease (MRD) positive at the end of induction as per local laboratory assessment\n\nExclusion Criteria:\n\nExclusion Criteria for All Study Phases:\n\n* Clinical evidence of central nervous system (CNS) leukemia\n* Any Grade ≥2 non-hematologic toxicities prior to starting therapy\n* Current treatment with any other investigational or commercial agents or therapies administered with the intention to treat their malignancy with the exception of hydroxyurea (HU) or 6-mercaptopurine (6-MP)\n* Treatment-related AML\n* Acute promyelocytic leukemia\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n* Any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the study, impair the ability of the investigator to evaluate the patient, or impair the patient's ability to complete the study\n* Echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan showing ejection fraction ≤40%\n* Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study treatment, such as hereditary coagulation disorders, insulin-dependent diabetes mellitus not optimally controlled with medical management (e.g., presence of ketoacidosis), or active GI conditions affecting absorption\n* Infection considered by the investigator to be clinically uncontrolled or of unacceptable risk to the patient upon the induction of neutropenia, that is, patients who are or should be on antimicrobial agents for the treatment of active infection\n* Febrile patients within 72 hours of study treatment initiation\n* Patients with a history of active or chronic infectious hepatitis unless serology demonstrates clearance of infection\n* Patients who are unable to interrupt treatment with moderate to strong CYP2C8 inducers and inhibitors\n* Patients who are unable to temporarily interrupt treatment with oral or parenteral anticoagulants\u002Fanti-platelet agents during treatment phase\n* Patients who have a history of clinically significant liver cirrhosis\n* Patients with extramedullary AML with no evidence of systemic involvement\n* Pregnant or breastfeeding patients\n* Known history of HIV-positive status\n* Patients who might refuse to receive blood products and\u002For have a hypersensitivity to blood products\n* Prior treatment with an MDM2 antagonist\n* Patients with clinically relevant QTc prolongation, a family history of long QT syndrome\n\nExclusion Criteria for Patients in the Phase Ib Dose-Escalation Phase:\n\n\\- Adverse risk patients as per European LeukemiaNet (ELN) 2017 criteria\n\nExclusion Criteria for Patients in Phase Ib Post-Consolidation Phase:\n\n* Any ongoing Grade ≥2 hematologic adverse events prior to starting therapy\n* Previous hematopoietic stem cell transplant (HSCT)\n\nExclusion Criteria for Patients in the Dose-Escalation Phase and Patients in the Favorable\u002FIntermediate-Risk Cohort of the Expansion Phase:\n\n\\- Secondary AML, defined as AML evolving from antecedent hematologic disorder (AHD)",false,"ALL","18 Years",{"count":320,"type":321},24,"ACTUAL","INTERVENTIONAL",[324,325],"PHASE1","PHASE2","This Phase Ib\u002FII, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).",[328],"Acute Myeloid Leukemia",[330],"AML","TERMINATED","Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2.","2022-06-16",{"date":335,"type":321},"2022-06-21",{"date":337,"type":321},"2019-03-25",{"date":339,"type":321},"2020-09-10",{"name":5,"class":6},26]