[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Servier Bio-Innovation LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"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":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100525874","phase-3-ivosidenib-in-participants-with-locally-advanced-or-metastatic-conventional-chondrosarcoma-untreated-or-previously-treated-with-1-systemic-treatment-regimen-100525874","NCT06127407","Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen","A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen","CHONQUER","Inclusion Criteria:\n\n* Have a histopathological diagnosis (fresh or banked tumor biopsy sample collected within the last 3 years) consistent with locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection.\n* Have at least one BICR-confirmed measurable lesion as defined by RECIST v1.1. Participants who have received prior radiation therapy are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment.\n* Have received 0 or 1 prior systemic treatment regimen in the advanced\u002Fmetastatic setting for chondrosarcoma.\n* Have radiographic progression\u002Frecurrence of disease according to RECIST v1.1 defined as:\n\n  1. Radiographic progression of disease (local and\u002For distant) documented by 2 imaging assessments performed no more than 6 months (±2 weeks) apart within 12 months before randomization.\n\n     OR\n  2. Any recurrence of disease (local and\u002For distant) after complete surgical resection and documented by imaging within 6 months (±2 weeks) before randomization.\n* Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available that was sourced from either a primary or metastatic tumor lesion) based on central laboratory testing (R132C\u002FL\u002FG\u002FH\u002FS mutation variants tested)\n* Have recovered from any clinically relevant sequelae and toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.\n\nExclusion Criteria:\n\n* Are unable to swallow oral medication.\n* Pregnant or lactating women.\n* Are participating in another interventional study at the same time; participation in noninterventional registries or epidemiological studies is allowed.\n* Have received prior therapy with an IDH1 inhibitor\n* Have received systemic anticancer therapy \\\u003C2 weeks prior to randomization (for investigational or immune-based anticancer therapy \\\u003C4 weeks).\n* Have received radiotherapy \\\u003C2 weeks prior to randomization.\n* Have known symptomatic brain metastases requiring steroids \\>10 mg per day prednisone (or equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued or reduced corticosteroid treatment \\\u003C=10 mg per day for these metastases for at least 4 weeks and have radiographically stable disease of brain lesions for at least 3 months prior to randomization.\n* Have a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated carcinoma in situ; or c) pT1-2 prostatic cancer Gleason score \\\u003C6 or d) participant is free of other primary solid or liquid tumor for ≥ 1 year prior to the start of study treatment and, in the opinion of the Investigator, the disease will not affect participant's outcome in the setting of current chondrosarcoma diagnosis.\n* Have had major surgery within 4 weeks prior to randomization.\n* Have significant active cardiac disease within 6 months prior to randomization, including New York Heart Association (NYHA) Class III or IV congestive heart failure; myocardial infarction; unstable angina; and\u002For stroke.\n* Have LVEF \\\u003C40% by ECHO scan (or by other methods according to institutional practice) obtained within 28 days prior to randomization.\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 (eg, heart failure, hypokalemia, family history of long QT interval syndrome). Participants with a bundle branch block combined with a prolonged QTcF interval may be permitted based on local cardiology assessment.\n* Have known medical history of progressive multifocal leukoencephalopathy (PML).",{"count":49,"type":20},136,[51],"PHASE3","Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening\u002Fscreening phase. Participant must have radiographic progression\u002Frecurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced\u002Fmetastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants.\n\nParticipants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.",[54],"Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen",[56,57,58,59,60],"Conventional chondrosarcoma","IDH1","ivosidenib","locally advanced","metastatic","2026-02-04",{"date":63,"type":31},"2026-02-06",{"date":65,"type":31},"2024-07-09",{"date":67,"type":20},"2030-11-26",{"name":37,"class":38},114,""]