[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591282":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":51,"studyPopulation":48,"armGroups":52,"interventions":59,"overallOfficials":64,"centralContacts":68,"locations":77,"responsibleParty":95,"collaborators":97,"id":108,"slug":48,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":48,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":48,"enrollmentInfo":116,"targetDuration":48,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":79,"whyStopped":48,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Blokhin's Russian Cancer Research Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate","From date of enrollment until the date of first documented objective response","assessed at 8 and 16 weeks",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Progression-free survival","From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first","assessed up to 24 months",{"measure":19,"description":20,"timeFrame":21},"Time to objective response","Time from start of treatment to objective response to treatment","assessed up to 12 months",{"measure":23,"description":24,"timeFrame":25},"Overall survival","From the time of enrolment until the death from any cause","assessed up to 36 months",[27,30,34,37,40],{"measure":28,"description":29,"timeFrame":21},"Duration of response","Calculated from achieving objective response to progression or death from any cause",{"measure":31,"description":32,"timeFrame":33},"Disease control rate","Percentage of patients who achieved a complete response, partial response or disease stabilisation","through study completion, an average of 1 year",{"measure":35,"description":36,"timeFrame":33},"Incidence of adverse events","Proportion of patients with adverse events out of all patients (NCI CTCAE 5.0)",{"measure":38,"description":39,"timeFrame":33},"Incidence of adverse events grade 3-4","Proportion of patients with adverse events grade 3-4 out of all patients (NCI CTCAE 5.0)",{"measure":41,"description":42,"timeFrame":33},"Frequency of dose reductions and drug withdrawals","Proportion of patients with dose reductions and drug withdrawals in the total number of patients",{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":48,"timePerspective":48,"maskingInfo":49},"NA","SINGLE_GROUP","* Drug: Dabrafenib\n* Drug: Cetuximab\n* Drug: Рanitumumab\n* Drug: Oxaliplatin\n* Drug: Irinotecan\n* Drug: Leucovorin\n* Drug: 5-FU","TREATMENT",null,{"masking":50,"maskingDescription":48,"whoMasked":48},"NONE","The purpose of the study is to evaluate the efficacy and toxicity of first-line FOLFOX with dabrafenib and cetuximab or panitumumab in patients with previously untreated metastatic inoperable colorectal cancer who have MSS and BRAF mutation.",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy","EXPERIMENTAL","mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy Dabrafenib 150 mg twice orally daily Cetuximab 500 mg\u002Fm2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg\u002Fkg (60-minute IV infusion) every two weeks Oxaliplatin 85 mg\u002Fm2 (120-minute IV infusion) every two weeks, Сalcium folinate 400 mg\u002Fm2 (120-minute IV infusion) every two weeks 5-FU 400 mg\u002Fm2 IV bolus, then 5-FU 2400 mg\u002Fm2 continuous IV infusion over 46-48 hours every two weeks.\n\nIn the first-line setting, 8 courses are administered, and if disease control is achieved, dabrafenib, cetuximab or panitumumab therapy is continued until disease progression or intolerable toxicity.",[58],"Drug: mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy",[60],{"type":61,"name":54,"description":62,"armGroupLabels":63,"otherNames":48},"DRUG","Dabrafenib 150 mg twice orally daily Cetuximab 500 mg\u002Fm2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg\u002Fkg (60-minute IV infusion) every two weeks Oxaliplatin 85 mg\u002Fm2 (120-minute IV infusion) every two weeks, Сalcium folinate 400 mg\u002Fm2 (120-minute IV infusion) every two weeks 5-FU 400 mg\u002Fm2 IV bolus, then 5-FU 2400 mg\u002Fm2 continuous IV infusion over 46-48 hours every two weeks.",[54],[65],{"name":66,"affiliation":5,"role":67},"Mikhail Fedyanin MD","PRINCIPAL_INVESTIGATOR",[69,73],{"name":66,"role":70,"phone":71,"phoneExt":48,"email":72},"CONTACT","+7 905 704-33-18","fedianinmu@mail.ru",{"name":74,"role":70,"phone":75,"phoneExt":48,"email":76},"Evgenia Kuzmina MD","+7 9824012681","kuz011@mail.ru",[78],{"facility":5,"status":79,"city":80,"state":48,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Moscow","115193","Russia","RU",{"type":85,"coordinates":86},"Point",[87,88],37.61781,55.75204,{"lat":88,"lon":87},[91,94],{"name":92,"role":70,"phone":93,"phoneExt":48,"email":76},"Evgenia Kuzmina","89824012681",{"name":66,"role":70,"phone":71,"phoneExt":48,"email":72},{"type":96,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[98,101,103,106],{"name":99,"class":100},"City Clinical Oncology Hospital No 1","OTHER_GOV",{"name":102,"class":100},"Moscow City Oncology Hospital No. 62",{"name":104,"class":105},"The Loginov MCSC MHD","UNKNOWN",{"name":107,"class":100},"Moscow Multidisciplinary Clinical Center \"Kommunarka\"","100591282",false,"NCT06978400","A Study of Dabrafenib Plus Cetuximab\u002FPanitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer","Non-randomised, Multicentre, Prospective, Single-arm, Phase II Study of the Efficacy and Toxicity of a Combination of FOLFOX With Dabrafenib and Cetuximab\u002FPanitumumab in the First Line of Therapy of Patients With Metastatic BRAF V600E- Mutated MSS Colorectal Cancer","Inclusion Criteria:\n\n* Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation\n* Metastatic inoperable colorectal cancer\n* Adequate function of hematopoiesis and basic indicators of internal organs\n* Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).\n* Lacking antitumor systemic treatment for colorectal cancer.\n* Patients with progression after adjuvant chemotherapy may be included if progression is recorded no earlier than 12 months after the last course of chemotherapy.\n* The primary tumor is removed or asymptomatic.\n* Absence of grade 2 or higher neuropathy.\n* Absence of tumor MSI or dMMR.\n* ECOG PS 0-2\n\nExclusion Criteria:\n\n* Participants having more than 2 lines of treatment (a progression of disease within 12 months of the completion of adjuvant and\u002For perioperative chemotherapy with oxaliplatin and fluoropyrimidines is acceptable).\n* Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment.\n* Pregnant and breastfeeding women.\n* Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study.\n* HIV-infected patients.\n* Patients with a life expectancy of less than 3 months.\n* The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial.","ALL","18 Years",{"count":117,"type":118},64,"ESTIMATED","INTERVENTIONAL",[121],"PHASE2","The purpose of this study is to evaluate the efficacy and toxicity of FOLFOX regimen with dabrafenib and cetuximab\u002Fpanitumumab in the first line of therapy for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene and MSS.\n\nParticipants in this study will receive one of the following study treatments:\n\nThese participants will receive FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy This study is currently enrolling participants who will receive either FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy.\n\nThe study team will monitor how each participant responds to the study treatment for up to about 3 years.",[124],"Neoplasms",[126,127,128,129,130],"metastatic colorectal cancer","BRAF V600E- mutated","first line","MSS","treatment","2025-05-11",{"date":133,"type":134},"2025-05-18","ACTUAL",{"date":136,"type":134},"2025-03-01",{"date":138,"type":118},"2028-07-10",{"name":5,"class":6},1]