[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Servier Affaires Médicales\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100508948","phase-3-an-open-label-phase-3b-study-of-ivosidenib-in-combination-with-azacitidine-in-adult-patients-newly-diagnosed-with-idh1m-acute-myeloid-leukemia-aml-ineligible-for-intensive-induction-chemotherapy-100508948",false,"NCT05907057","An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.","A Single Arm, Open-label Phase 3b Study to Describe the Safety and Tolerability of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy","Inclusion Criteria:\n\n* Has untreated Acute Myeloid Leukemia (AML)\n* Have a documented IDH1 R132 gene-mutated disease\n* Have at least one of the following making yourself ineligible for intensive chemotherapy (IC): 75 years or older, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 2, or any comorbidity that the investigator judges to be incompatible with IC including but not limited to severe cardiac or pulmonary disorder, creatinine clearance less than 45 mL\u002Fminute, or bilirubin greater than 1.5 times the upper limit of normal\n* Has adequate hepatic (liver) and renal (kidney) function\n* Female participants of reproductive potential must have a negative blood pregnancy test and must use effective contraception during treatment and for at least 6 months following treatment\n* Fertile male participants with female partners of reproductive potential must use effective contraception during treatment and for at least 3 months following treatment\n\nExclusion Criteria:\n\n* Has received any prior treatment for AML, with the exception of hydroxyurea or leukapheresis for white blood cell count control\n* Has received prior treatment with an IDH1 inhibitor\n* Is a woman who is pregnant or breastfeeding\n* Has an active, uncontrolled, systemic fungal, bacterial, or viral infection (including human immunodeficiency virus \\[HIV\\], active hepatitis B (HBV), or hepatitis C virus \\[HCV\\]) without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment\n* Has had significant active cardiac disease within 6 months prior to the start of study treatment, including Class III or IV congestive heart failure, myocardial infarction (heart attack), unstable angina (chest pain), and\u002For stroke\n* Has dysphagia (difficulty swallowing), short-gut syndrome, gastroparesis (stomach paralysis), or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs\n* Has uncontrolled hypertension (high blood pressure)","ALL","18 Years",{"count":19,"type":20},245,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive \\[IDH1m\\]) and cannot receive treatment with intensive chemotherapy (IC).",[26],"Acute Myeloid Leukemia (AML)",[28],"IDH1 Mutation AML","RECRUITING","2026-05-06",{"date":32,"type":33},"2026-05-08","ACTUAL",{"date":35,"type":33},"2023-06-14",{"date":37,"type":20},"2027-10-15",{"name":39,"class":40},"Servier Affaires Médicales","INDUSTRY",15,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100506620","phase-3-an-early-access-study-of-ivosidenib-in-patients-with-a-pretreated-locally-advanced-or-metastatic-cholangiocarcinoma-100506620","NCT05876754","An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma","An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma","ProvIDHe","Inclusion Criteria:\n\n* Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies\n* Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease\n* Have tried at least 1 prior type of systemic therapy for CCA, and have recovered from any side effects\n* Female patients of childbearing potential must have a negative blood pregnancy test prior to starting treatment and must agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug\n* Male patients with a female partner with childbearing potential must also agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug\n\nExclusion Criteria:\n\n* Received a prior IDH1 inhibitor\n* Have received a transplant\n* Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1\n* Have received hepatic radiation, chemoembolization, and radiofrequency ablation within 4 weeks prior to Day 1 of Cycle 1\n* Have ongoing brain metastases requiring steroids\n* Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1\n* Have an active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness\n* Are pregnant or breastfeeding",{"count":51,"type":20},220,[23],"A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.",[55],"Cholangiocarcinoma",[57,58],"CCA","Pretreated locally advanced or metastatic cholangiocarcinoma","2026-02-17",{"date":61,"type":33},"2026-02-19",{"date":63,"type":33},"2023-05-03",{"date":65,"type":20},"2027-12-01",{"name":39,"class":40},84,""]