[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595414":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":83,"collaborators":87,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":11,"enrollmentInfo":101,"targetDuration":11,"studyType":104,"phases":105,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":116,"whyStopped":11,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"D'Or Institute for Research and Education","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients who developed severe (grade 3 or higher) toxicities from the use of Fluoropyrimidines","EXPERIMENTAL",null,[13],"Drug: I-01\u002F23",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","I-01\u002F23","The I-01\u002F23 will be administered over a 5-day period, with dosing adjusted according to the patient's body surface area (BSA).",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Intituto D'Or de Pesquisa e Ensino São Paulo","CONTACT","pesquisaclinica@idor.org","oncologia.projetos@idor.org",[27,41,52,63,73],{"facility":28,"status":11,"city":29,"state":30,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Instituto D'Or de Pesquisa e Ensino de Salvador","Salvador","Estado de Bahia","Brazil","BR",{"type":34,"coordinates":35},"Point",[36,37],-38.49096,-12.97563,{"lat":37,"lon":36},[40],{"name":11,"role":23,"phone":24,"phoneExt":11,"email":25},{"facility":42,"status":11,"city":43,"state":44,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":45,"geoPoint":49,"contacts":50},"Instituto D'Or de Pesquisa e Ensino de Brasília","Brasília","Federal District",{"type":34,"coordinates":46},[47,48],-47.92972,-15.77972,{"lat":48,"lon":47},[51],{"name":11,"role":23,"phone":24,"phoneExt":11,"email":25},{"facility":53,"status":11,"city":54,"state":55,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Instituto D'Or de Pesquisa e Ensino de Curitiba","Curitiba","Paraná",{"type":34,"coordinates":57},[58,59],-49.27306,-25.42778,{"lat":59,"lon":58},[62],{"name":11,"role":23,"phone":24,"phoneExt":11,"email":25},{"facility":64,"status":11,"city":65,"state":65,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Instituto D'Or de Pesquisa e Ensino do Rio de Janeiro","Rio de Janeiro",{"type":34,"coordinates":67},[68,69],-43.18223,-22.90642,{"lat":69,"lon":68},[72],{"name":11,"role":23,"phone":24,"phoneExt":11,"email":25},{"facility":74,"status":11,"city":75,"state":75,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Instituto D'Or de Pesquisa e Ensino de São Paulo","São Paulo",{"type":34,"coordinates":77},[78,79],-46.63611,-23.5475,{"lat":79,"lon":78},[82],{"name":11,"role":23,"phone":24,"phoneExt":11,"email":25},{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Camila Motta Venchiarutti Moniz","Doctor, Principal Investigator",[88],{"name":89,"class":90},"Conselho Nacional de Desenvolvimento Científico e Tecnológico","OTHER_GOV","100595414","phase-1-dose-optimization-and-efficacy-assessment-of-a-fluoropyrimidine-antidote-100595414",false,"NCT07032142","Dose Optimization and Efficacy Assessment of a Fluoropyrimidine Antidote","A Phase I\u002FII Trial to Evaluation of the Dose and Efficacy of an Antidote to Fluoropyrimidines","ARCTURUS","Inclusion Criteria:\n\nPresence of at least one severe toxicity or intoxication resulting from fluoropyrimidine use, defined as: receiving an overdose of medication (total dose and\u002For infusion rate higher than recommended in the package insert) and\u002For Grade 3 or 4 serious adverse events after fluoropyrimidine exposure, according to CTCAE v5.0, which may include (but are not limited to): nausea, vomiting, diarrhea, anemia, neutropenia, febrile neutropenia, thrombocytopenia, and mucositis;\n\nLack of access to uridine triacetate (UT) in the standard of care;\n\nDiagnosis of an invasive solid tumor under systemic treatment with a fluoropyrimidine (5-fluorouracil or capecitabine);\n\nOrgan function considered adequate by the investigator prior to the current fluoropyrimidine intoxication episode;\n\nAbility to take oral medication;\n\nFor men and women of reproductive potential, agreement to practice abstinence or use highly effective contraceptive methods during study participation and for at least 6 months after the last dose of IP;\n\nMen must agree not to donate sperm for at least 6 months after the last dose of IP;\n\nBody surface area between 1.4 and 2.4 m², calculated using the Du Bois method;\n\nAST\u002FALT within normal limits for participants without liver metastases;\n\nAST\u002FALT up to 3x the upper limit of normal in participants with liver metastases;\n\nTotal and fractionated bilirubin up to 2x the upper limit of normal;\n\nAgreement to abstain from alcohol consumption during the treatment period;\n\nAs a specific inclusion criterion for participants in Phase 1 of the study: a medical indication, according to routine care, for hospitalization of at least 48 hours for the clinical management of fluoropyrimidine-related toxicity.\n\nExclusion Criteria:\n\nPregnant or breastfeeding women;\n\nKnown history of allergic reaction to the molecules of the copound and\u002For to other molecules in the same class;\n\nLife expectancy of less than 30 days prior to hospital admission, based on underlying cancer and existing comorbidities;\n\nEstimated creatinine clearance \\\u003C70 mL\u002Fmin;\n\nLiver cirrhosis;\n\nKnown liver or kidney disease;\n\nIndividuals with acquired immunodeficiency may be included only if they have no active opportunistic infections and following careful clinical assessment by the investigator, taking into account concurrent medications;\n\nFamily history or known deficiency of the enzyme responsible for metabolizing the molecules of the copound and\u002For to other molecules in the same class;\n\nUncontrolled infection;\n\nHemodynamically unstable patients;\n\nPatients under orotracheal intubation;\n\nPatients unable to take oral medication;\n\nProlonged QT interval;\n\nCNS metastases considered uncontrolled by the investigator;\n\nHistory of malabsorptive or inflammatory gastrointestinal disease;\n\nUse within the last 30 days of lactulose, protease inhibitors, amiodarone, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, or rifapentine;\n\nUse within the last 5 days of dietary supplements containing the molecules of the copound;\n\nUse within the last 30 days of drugs classified as anticonvulsants;\n\nPersonal history of seizures;\n\nComorbidities deemed limiting by the investigator;\n\nHistory of renal or liver transplant;\n\nPresence of intestinal obstruction.","ALL","18 Years",{"count":102,"type":103},66,"ESTIMATED","INTERVENTIONAL",[106,107],"PHASE1","PHASE2","Fluoropyrimidines (FLU) are drugs widely used in chemotherapy for various tumors, such as breast, colon, rectal, and gastric cancers. FLU is a drug that inhibits thymine synthesis and, consequently, DNA synthesis, leading to tumor cell death. However, up to 30% of patients treated with FLU experience severe toxicities, depending on the dose and regimen received. The most common symptoms include mucositis, vomiting, nausea, diarrhea, and neutropenia.\n\nThe enzyme dihydropyrimidine dehydrogenase (DPD) plays a key role in FLU metabolism. Patients with mutations in the DPYD gene (which encodes DPD) are at high risk of experiencing severe toxicities from FLU. Uridine triacetate (UT) is a drug that can be used as an antidote for 5-FU in patients who develop severe toxicities. However, despite its efficacy, it is expensive and not commercially available in Brazil.\n\nCurrently, the Brazilian population has no access to an antidote for the treatment of FLU-related toxicities. This Phase I\u002FII study will evaluate the dose, safety, and efficacy of compound the association of two molecules as an antidote for grade 3 or higher toxicities resulting from the use of FLU.",[110,111],"Cancer","Toxicity Due to Chemotherapy",[113,114,115],"cancer","fluoropyrimidines","Toxicities from Fluoropyrimidines","NOT_YET_RECRUITING","2025-06-13",{"date":119,"type":120},"2025-06-22","ACTUAL",{"date":122,"type":103},"2025-07",{"date":124,"type":103},"2028-07",{"name":5,"class":6},5]