[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idh1-mutated-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idh1-mutated-malignancies":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100593457","phase-1-a-study-of-an-idh1m-inhibitor-in-participants-with-idh1-mutated-malignancies-and-hepatic-or-renal-impairment-100593457",false,"NCT07006688","A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment","A Phase 1, Multicenter, Open-Label, Safety and Pharmacokinetic Study of Orally Administered Ivosidenib in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment","Inclusion Criteria:\n\n* Participants with hematologic malignancies (including but not limited to acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasms, clonal cytopenia of unknown significance with a high-risk score \\[CHRS ≥12.5\\], chronic myelomonocytic leukemia, multiple myeloma, and non-Hodgkin's lymphoma) or solid tumors excluding glioma, with a locally confirmed IDH1 R132 mutation before Cycle 1 Day 1.\n* Based on renal and hepatic function, participants within the:\n\n  a. Moderate HI group, must have: i. Total bilirubin \\>1.5 to 3 × upper limit of normal (ULN), not linked to Gilbert's disease, and any aspartate aminotransferase (AST) value, ii. Adequate renal function as evidenced by creatinine clearance (CrCl) ≥60 mL\u002Fmin estimated according to the Cockcroft-Gault formula. b. Severe HI group, must have: i. Total bilirubin \\>3 × ULN and any AST value, ii. Adequate renal function as evidenced by CrCl\n\n  ≥60 mL\u002Fmin estimated according to the Cockcroft-Gault formula. c. Severe RI group, must have: i. CrCl ≥15 to 29 mL\u002Fmin estimated according to the Cockcroft-Gault formula, ii. Adequate hepatic function as evidenced by:\n  1. Blood total bilirubin ≤1.5 × ULN, unless due to Gilbert's disease, where participants should have blood total bilirubin ≤3 × ULN;\n  2. AST, alanine aminotransferase, and alkaline phosphatase ≤3.0 × ULN\n* Participants of the control groups with adequate hepatic or renal function characterized as:\n\n  1. Hepatic control group: Adequate hepatic function as evidenced by total bilirubin and AST ≤ULN, and normal to mild RI (CrCl ≥60 mL\u002Fmin estimated according to the Cockcroft-Gault formula).\n  2. Renal control group: Adequate renal function as evidenced by CrCl ≥90 mL\u002Fmin (estimated according to the Cockcroft-Gault formula) and normal to mild HI (total bilirubin ≤1.5 × ULN, participants with Gilbert's disease should have blood total bilirubin ≤3 × ULN).\n* Participants previously or currently treated with ivosidenib are eligible if treated at the 500 mg QD dose or if treated at the 250 mg QD dose due to strong cytochrome P450 (CYP)3A4 inhibitor intake. Participants with a hematologic malignancy on co-treatment with azacitidine are also eligible.\n* WOCBP must agree to abstain from sexual intercourse or use 2 effective methods of birth control (a highly effective method and a barrier method) from the time of giving informed consent throughout the study and for 90 days after the last dose of ivosidenib. Hormonal contraception alone is not considered an acceptable method of contraception and should be combined with a barrier method.\n\nExclusion Criteria:\n\n* Have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of ivosidenib, or on immunosuppressive therapy post-HSCT at the time of screening, or with active acute or chronic graft-versus-host-disease (GVHD) requiring systemic therapy. (Participants with GVHD managed by minimal interventions \\[a physiologic dose of steroids\\] are permitted with the medical monitor's approval.)\n* Have received systemic anticancer therapy (with the exception of azacitidine), investigational agent treatment, or radiotherapy \\\u003C14 days, or had surgery \\\u003C4 weeks before planned Cycle 1 Day 1 of ivosidenib, and\u002For did not recover from the AEs associated with these therapies and\u002For surgeries. In addition, the first dose of ivosidenib should not occur before a period of ≥5 half-lives of the study drug has elapsed.\n* Have hematological diseases (other than AML or MDS) or solid tumors that are eligible for other treatments known to provide clinical benefit.\n* Have received calcineurin inhibitors within 4 weeks prior to enrollment.\n* Have significant active cardiac disease within 6 months before the start of ivosidenib, including NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina, and\u002For stroke.\n* Use of any medications that are known to prolong the QT interval unless they can be transferred to other medications within ≥5 half-lives before dosing or unless the medications can be properly monitored during the study. (If equivalent medication is not available, QTcF should be closely monitored).\n* Planned use of any strong CYP3A4 inducer or sensitive CYP3A4 substrate with a narrow therapeutic window or certain antifungals that are CYP3A4 substrates while the participant is receiving ivosidenib. Participants who are taking these medications must have the minimum washout period of ≥5 half-lives before the first dose of ivosidenib and not take the medications for the duration of their participation in the study.\n* Have known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or laparoscopic gastric banding, short-gut syndrome, gastroparesis, or other active conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential).\n* Have a known familial history of sudden death or polymorphic ventricular arrhythmia.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The objective of this study is to investigate the PK, PD, safety, and tolerability of ivosidenib in adult participants with IDH1-mutated malignancies and hepatic impairment (HI)\u002F renal impairment (RI). Participants will be enrolled into one of 5 groups based on their hepatic or renal function. During the treatment period participants will have study visits on days 1, 4, 8, 15, 22, and 28 of Cycle 1, on days 1 and 15 of Cycle 2 and 3, and on day 1 of each additional cycle. Each cycle is 28 consecutive days of treatment and cycles will be continuous until the end of the study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur. Study visits may include blood tests, ECG, vital signs, and a physical examination.",[26],"IDH1-Mutated Malignancies","RECRUITING","2026-05-11",{"date":30,"type":31},"2026-05-12","ACTUAL",{"date":33,"type":31},"2026-01-14",{"date":35,"type":20},"2028-08-31",{"name":37,"class":38},"Servier Bio-Innovation LLC","INDUSTRY",19,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100595459","phase-2-olutasidenib-combined-with-co-targeted-therapy-in-relapsed-or-refractory-idh1-mutated-myeloid-malignancies-harboring-activated-signaling-pathway-mutations-100595459","NCT07032727","Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations","Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Participants with a diagnosis of relapsed and\u002For refractory AML (including biphenotypic or bilineage leukemia including a myeloid component) OR high-risk MDS, MPN, or MDS\u002FMPN (defined as ≥10% blasts on peripheral flow cytometry or bone marrow biopsy).\n3. Participants must have a documented IDH1 mutation.\n4. Participants must also have a documented co-signaling mutation in one or more of the following: KRAS, NRAS, PTPN11, CBL, NF1, FLT3-ITD, FLT3-TKD, KIT, JAK2, MPL, CALR, CSF3R.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.\n6. Adequate renal function with estimated GFR ≥ 30 by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).\n7. Adequate hepatic function, defined as direct bilirubin ≤ 2x upper limit of normal (ULN) and AST and ALT ≤ 3x ULN unless the increase is due to Gilbert's disease or leukemic involvement, in which case direct bilirubin, AST, and ALT ≤ 5x ULN will be considered eligible.\n8. The interval from prior treatment to time of initiation will be at least 14 days OR five half-lives for both cytotoxic and non-cytotoxic (e.g. immunotherapy agent(s)). Oral hydroxyurea and\u002For cytarabine (up to 2g\u002Fm2) is allowed for participants with rapidly proliferative disease prior tothe start and during the first two cycles of therapy, for clinical benefit and after discussion with the PI. Continuation of concurrent intrathecal therapy for controlled CNS disease is permitted.\n9. Ability to understand and the willingness to sign an informed consent document.\n\nExclusion Criteria\n\n1. Participants who have received prior olutasidenib (Rezlidhiai, previously FT-2102).\n2. Participants with translocation t(15;17) or acute promyelocytic leukemia (French-American British (FAB) class M3-AML).\n3. Participants with any concurrent uncontrolled clinically significant medical condition, including life threatening infection, which could place the patient at unacceptable risk of study treatment.\n4. Participants with any uncontrolled psychiatric illness that would limit compliance with study requirements.\n5. Participants with a New York Heart Association (NYHA) Functional Classification of III or IV.\n\n   • Participants with active graft-versus-host-disease (GVHD) status post stem cell transplant (Participants without active GVHD on phototherapy for chronic skin GVHD are permitted after discussion with the PI). Participants must have discontinued calcineurin inhibitors at least 4 weeks prior to the start of study treatment.\n6. Participants with active, uncontrolled CNS leukemia.\n7. Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n8. Known active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) infection. For participants with evidence of chronic HBV or HIV infection, the HBV or HIV viral load must be undetectable, respectively. For participants with a history of HCV, it must be treated and cured with an undetectable HCV viral load.\n9. Participant has white blood cell count \\>25 x 109\u002FL (Note: Hydroxyurea and cytarabine are permitted to mean this criterion).\n10. The effects of the study drug on the developing human fetus or transmission through breast feeding are unknown. Therefore, nursing women and women with a positive urine pregnancy test and excluded. Additionally, women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP who are not willing to maintain adequate contraception are excluded.\n\n    a. WOCBP includes all female participants between the onset of menses (as early as 8 years of age) to 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n\n    ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n    iv. History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    b. Approved methods of birth control are as follows: hormonal contraception (i.e. birth control pills, injection, transdermal patch, vaginal ring, hormonal implant), intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post-vasectomy, double barrier methods (e.g. condom in combination with spermicide). Abstinence for the duration of the trial and drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately.\n\n    c. Adequate contraception must be maintained from initiation of the study drug until 90 days after the last dose of the study drug.\n11. History of an allergic reaction to venetoclax, gilteritinib, ruxolitinib, cladribine, or cytarabine.",{"count":47,"type":20},68,[49],"PHASE2","To learn about the safety and tolerability of study drug combinations in patients with relapsed\u002Frefractory, IDH1-mutated myeloid malignancies with a co-signaling mutation.",[52,26,53],"Targeted Therapy","Mutations","2026-04-13",{"date":56,"type":31},"2026-04-15",{"date":58,"type":31},"2025-09-12",{"date":60,"type":20},"2029-06-01",{"name":62,"class":63},"M.D. Anderson Cancer Center","OTHER",1]