[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institut de Recherches Internationales Servier (I.R.I.S.)\",\"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,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100612211","phase-1-pharmacokinetic-study-of-vorasidenib-in-severe-hepatically-impaired-and-matched-control-participants-100612211",false,"NCT07250633","Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants","A Phase 1, Open-Label, Non-randomized, Single Dose, Safety, Tolerability, and Pharmacokinetic Study of Vorasidenib Administered to Participants With Severe Hepatic Impairment and Matched-Participants With Normal Hepatic Function","Inclusion Criteria:\n\nParticipants with hepatic impairment:\n\n* Diagnosis of cirrhosis due to parenchymal liver disease\n* Considered to have a Child-Pugh score of 10 to 15, consistent with severe HI, and a documented medical history of liver disease. Participants must be clinically stable (no acute episodes of illness due to deterioration in hepatic function) for at least 1 month prior to screening and are likely to remain stable throughout the study.\n* Grade 0 or Grade 1 hepatic encephalopathy considered stable per Investigator assessment without exacerbation within the 6 months prior to screening.\n* Currently on a stable medication regimen, defined as not starting new drug(s) or significantly changing drug dosage(s) within 14 days preceding Day 1.\n* Non-hepatic abnormal laboratory values must be not clinically significant as judged by the Investigator (or designee) and the study medical monitor.\n* Anemia secondary to hepatic disease is acceptable if hemoglobin is ≥ 9 g\u002FdL and anemia symptoms are not clinically significant. Platelet count must be ≥ 35,000 platelets.\n* QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≤ 480 msec.\n\nMatched-control participants:\n\n* Healthy, with normal hepatic function with a Child-Pugh score below 5.\n* Resting blood pressure of 90 to 140 mmHg (systolic) and 40 to 90 mmHg (diastolic).\n* QTcF of ≤ 450 msec.\n* Participant must match hepatically impaired participants with respect to sex, race, age (±10 years), smoking status (smoke or vape ≤ 10 cigarettes\u002Fday), and body mass index (±20%).\n\nExclusion Criteria for all participants:\n\n* Women of childbearing potential (WOCBP) who are pregnant, lactating, or planning to become pregnant within 90 days after the dose of vorasidenib.\n* The participant is using hormonal contraceptives\n* Use of any other investigational drug or device within 30 days (or 5 half-lives if known, whichever is longer) before the dose of vorasidenib\n* Consumption of any nutrients known to modulate CYP450 enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, Seville \\[blood\\] orange products) within 14 days before vorasidenib administration.\n* Consumption of alcohol-containing foods or beverages or caffeine- or xanthine-containing foods or beverages (including, but not limited to, teas \\[including decaffeinated teas\\], coffees \\[including decaffeinated coffees\\], colas \\[including decaffeinated colas\\], energy drinks, gum containing caffeine, and chocolate (including foods and beverages containing chocolate) within 48 hours prior to admission\n* Any history (within 5 years prior to screening) or presence of malignancy, except for adequately treated basal cell and squamous cell carcinoma of the skin\n* History within the previous 12 months of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 12 oz beer, 5 oz wine, or 1.5 oz spirits)\n* In the opinion of the Investigator, the participant is not suitable for entry into the study",true,"ALL","18 Years","75 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of one dose of vorasidenib in participants with severe impaired hepatic function compared to participants with normal hepatic function. The study includes a screening phase, a treatment period, and a follow-up period. During the first part of the treatment period, from Day 1 through Day 4, participants will remain in-house in the clinical research unit. In the second part of the treatment period, from Day 5 through Day 43, participants can go home but may also choose to remain in-house. The entire study, including screening and follow-up, will last up to 77 days. Participants may undergo blood tests, heart tests (electrocardiogram (ECG)), vital sign checks, and physical exams.",[28,29],"Severe Hepatic Impairment","Normal Hepatic Function","RECRUITING","2026-06-03",{"date":33,"type":34},"2026-06-05","ACTUAL",{"date":36,"type":34},"2026-04-23",{"date":38,"type":22},"2026-11-23",{"name":40,"class":41},"Institut de Recherches Internationales Servier (I.R.I.S.)","INDUSTRY",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100614953","phase-2-vorasidenib-study-in-pediatric-participants-with-grade-2-astrocytoma-or-oligodendroglioma-with-an-idh1-or-idh2-mutation-100614953","NCT07286292","Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation","A Phase 2, Single Arm, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Vorasidenib in Pediatric Participants Aged 12 to \u003C 18 Years Old With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation","Inclusion Criteria:\n\n* Weigh ≥ 25 kg at Screening.\n* Written informed consent\u002Fassent must be obtained from a legally authorized representative, and assent must be obtained from the participant in accordance with local regulations. Participants and their families must be willing and able to comply with the scheduled visits, treatment plans, procedures, and laboratory tests, including serial peripheral blood sampling, during the study.\n* Have Grade 2 astrocytoma or oligodendroglioma per World Health Organisation (WHO) 2021 criteria.\n* Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection) and no other prior anticancer therapy, including chemotherapy and radiotherapy, and do not need immediate chemotherapy or radiotherapy in the opinion of the Investigator.\n* Have:\n* Confirmed IDH1 or IDH2 gene mutation, as well as known 1p19q and\u002For ATRX (Alpha Thalassemia\u002FMental Retardation Syndrome X-linked) status based on local testing of tumor tissue by an accredited laboratory.\n* For astrocytoma: Absence of 1p19q co-deletion and\u002For documented loss of nuclear ATRX expression or ATRX mutation by local testing.\n* For oligodendroglioma: Presence of 1p19q co-deletion by local testing.\n* Have magnetic resonance imaging (MRI)-evaluable, measurable, non-enhancing disease\n* Have a Karnofsky Performance Score (KPS; for participants ≥ 16 years of age) or Lansky Play-Performance Scale (LPPS; for participants \\\u003C 16 years of age) score of ≥ 70. Karnofsky Performance Score and LPPS \\\u003C 70 due to functional limitations as a result of prior surgical resections or due to the anatomical location of the tumor will be permitted.\n* Have adequate bone marrow function as evidenced by:\n* Absolute neutrophil count ≥ 1500\u002Fmm3 or ≥ 1.5 × 109\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Platelets ≥ 100,000\u002Fmm3 or ≥ 100 × 109\u002FL\n* Have adequate hepatic function as evidenced by:\n* Serum total bilirubin ≤ 1.5 × ULN; if \\> 1.5 ULN and due to Gilbert syndrome, total bilirubin ≤ 3 × ULN with direct bilirubin ≤ ULN\n* AST at or below ULN and ALT at or below ULN\n* Alkaline phosphatase (ALP) ≤ 2.5 × ULN\n* Have adequate renal function as evidenced by:\n* Serum creatinine ≤ 2.5 × ULN, OR\n* eGFR \\> 40 mL\u002Fmin\u002F1.73 m2 based on the Bedside Schwartz method 0.413 × (Height in cm\u002FSerum Creatinine in mg\u002FdL)\n* Have recovered from any clinically relevant toxicities associated with any prior surgery for the treatment of glioma unless stabilized under medical management (functional limitations as a result of prior surgical resections or due to the anatomical location of the tumor will be permitted).\n* Female participants of reproductive potential must have a negative serum pregnancy test before starting investigational medicinal product (IMP).\n* Women of childbearing potential as well as fertile male participants with female partners of reproductive potential, must agree to abstain from sexual intercourse or to use 2 effective methods of contraception from screening until at least 90 days after the last dose of IMP.\n\nExclusion Criteria:\n\n* Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including, but not limited to, systemic chemotherapy, radiotherapy, vaccines, small molecule inhibitors, IDH inhibitors, and investigational agents.\n* Have features assessed as high-risk by the Investigator.\n* Have leptomeningeal disease.\n* Concurrent active malignancy except for curatively resected nonmelanoma skin cancer or curatively treated carcinoma in situ. Participants with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.\n* Unable to swallow oral medication.\n* Are pregnant or breastfeeding.\n* Are participating in another interventional study at the same time; participation in non-interventional registries or epidemiological studies is allowed.\n* Have a severe or uncontrolled active acute or chronic infection or an unexplained fever \\> 38.5°C within 7 days of C1D1.\n* Have a known hypersensitivity to any of the components of vorasidenib.\n* Have significant active cardiac disease within 6 months before the start of IMP, including New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, and\u002For stroke.\n* Have a heart-rate corrected QT interval using Fridericia's formula (QTcF) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events.\n* Are taking therapeutic doses of steroids (defined as \\> 1.5 mg\u002Fday dexamethasone or \\>10 mg\u002Fday prednisone or equivalent) for signs\u002Fsymptoms of glioma. Participants taking physiologic doses (defined as ≤ 1.5 mg\u002Fday dexamethasone or ≤ 10 mg\u002Fday prednisone or equivalent) for medical conditions not related to glioma will be permitted.\n* Are taking any medications that are CYP2C19 or CYP3A substrates with a narrow therapeutic index or strong inhibitors of CYP1A2.\n* Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus (HIV) antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV or HIV that is adequately suppressed by institutional practice will be permitted.\n* Have known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the ingestion or gastrointestinal absorption of drugs administered orally. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential).\n* Have any other acute or chronic medical or psychiatric condition.","12 Years","17 Years",{"count":53,"type":22},10,[55],"PHASE2","The objective of this study is to evaluate the safety, tolerability, efficacy profile, and effect on growth and development of vorasidenib in pediatric participants aged 12 to \\\u003C 18 years old with grade 2 glioma with an IDH1 or IDH2 mutation. The study includes a screening period, a treatment period consisting of continuous 28-day cycles of treatment, a safety follow-up period and a long-term follow-up period. The long-term follow-up period will assess participants for growth, development, and long-term safety impacts for approximately 5 years after the start of treatment or until Tanner Stage V is reached (whichever is later). Participants may undergo blood tests, heart tests (electrocardiogram (ECG)), imaging (MRI, X-ray), vital sign checks, and physical exams.",[58],"Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation","NOT_YET_RECRUITING","2025-12-10",{"date":62,"type":34},"2025-12-16",{"date":64,"type":22},"2026-03-15",{"date":66,"type":22},"2033-05-02",{"name":40,"class":41},""]