[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thyroid-carcinoma-anaplastic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thyroid-carcinoma-anaplastic":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,78,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":47,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100626796","phase-2-determine-trial-treatment-arm-07-dabrafenib-in-combination-with-trametinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-braf-v600-mutation-positive-cancers-100626796",false,"NCT07440290","DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\\* \\*When dabrafenib- and trametinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.\n\nB. Patients ≥1 year old and ≥8 kg in body weight.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n• Have a negative serum or urine pregnancy test before enrolment and;\n\n• Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nPatients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks after the last administration of dabrafenib and 16 weeks after the last administration of trametinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male partners with partners who are women of childbearing potential should also be advised of the benefit for their partner of using a highly effective method of contraception, such as:\n\n  i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]), ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), iii. IUD, iv. intrauterine hormone-releasing system (IUS), v. bilateral tubal occlusion, vi. total sexual abstinence.\n* Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.\n* Male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility\n\nExclusion criteria:\n\nA. Diagnosis of one of the following BRAF V600E mutation-positive cancers:\n\n* Colorectal cancer in adult (≥18 years) patients;\n* Unresectable or metastatic melanoma in adult (≥18 years) patients;\n* Advanced non-small cell lung cancer in adult (≥18 years) patients;\n* Gliomas harbouring a BRAF V600E mutation in paediatric (1 to \\\u003C16 years) or TYA (16 to \\\u003C18 years) patients.\n\nB. Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for two weeks following their last dose of dabrafenib or 16 weeks following their last dose of trametinib, whichever is later.\n\nD. Known hypersensitivity to dabrafenib or trametinib or any of the excipients. See the current relevant SmPCs (UK) for the full lists.\n\nE. Patients with a history of retinal vein occlusion.\n\nF. Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and\u002For trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).\n\nG. Clinically significant cardiac or cerebrovascular disease as defined by:\n\n* Unstable angina within three months prior to screening;\n* Myocardial infarction within three months prior to screening;\n* History of documented congestive heart failure (New York Heart Association functional classification III\u002FIV) etc.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months prior to screening.\n\n• Patients with primary central nervous system (CNS) tumours may be considered unless intratumoural bleeding has occurred within two weeks prior to the first dose of dabrafenib and trametinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. Patients who were administered a live, attenuated vaccine within 28 days prior to initiation of treatment, or anticipation of need for such a vaccine during investigational medicinal product (IMP) treatment or within six months after the final dose of dabrafenib and trametinib.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of dabrafenib and trametinib including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided that each of the following conditions are met:\n\n* CD4 count ≥350\u002FµL;\n* Undetectable viral load;\n* Receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* No HIV\u002Facquired immune deficiency syndrome associated opportunistic infection in the last 12 months.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.","ALL","1 Year",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.\n\nInvestigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Haematological Malignancy","Malignant Neoplasm","Lymphoproliferative Disorders","Neoplasms by Histologic Type","Neoplasms by Site","Gastrointestinal Cancer","Non-Melanoma Skin Cancer (NMSC)","Langerhans Cell Histiocytosis (LCH)","Cancer","Erdheim-Chester Disease","Thyroid Carcinoma, Papillary","Ovarian Neoplasms","Colorectal Neoplasms","Laryngeal Neoplasms","Carcinoma, Non-Small Cell-Lung","Glioma","Multiple Myeloma","Thyroid Carcinoma, Anaplastic","Solid Tumour",[48,49,36,50,51,52,53,54,55,56,32,57,58,59,60,61,62,63,64],"Adult","Antineoplastic Agents","Child","Dabrafenib","Malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Paediatric","Precision Medicine","Proto-Oncogene Proteins B-raf","Protein Kinase Inhibitors","Rare","Trametinib","Tumour-Agnostic","Young adult","NOT_YET_RECRUITING","2026-02-23",{"date":68,"type":69},"2026-02-27","ACTUAL",{"date":71,"type":21},"2026-02",{"date":73,"type":21},"2029-10",{"name":75,"class":76},"Cancer Research UK","OTHER",27,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":15,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":105},"100498278","phase-2-determine-trial-treatment-arm-05-vemurafenib-in-combination-with-cobimetinib-in-adult-patients-with-braf-positive-cancers-100498278","NCT05768178","DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 05 (VEMURAFENIB AND COBIMETINIB) OUTLINED BELOW\\*\n\n\\*When vemurafenib and cobimetinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the vemurafenib and cobimetinib-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring any actionable BRAF V600 mutation using an analytically validated next-generation sequencing method.\n\nB. Adult patients ≥18 years old.\n\nC. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nD. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nE. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and;\n* Agree to sexual abstinence OR to use any two forms of highly effective or effective methods together (at least one to be non-hormonal) such as:\n\n  * Highly effective methods:\n* combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n* progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n* intrauterine device (IUD)\n* intrauterine hormone-releasing system (IUS)\n* bilateral tubal occlusion\n* vasectomised partner\n\n  * Effective methods:\n* progestogen-only oral hormonal contraception not associated with inhibition of ovulation\n* male or female condom with or without spermicide\n* cap, diaphragm or sponge with spermicide\n\nEffective from the first administration of vemurafenib or cobimetinib (whichever is first), throughout the trial and for six months after the last administration of vemurafenib or cobimetinib (whichever is later).\n\nF. Male patients with partners who are women of childbearing potential, are eligible provided that they agree to the following, from the first administration of vemurafenib or cobimetinib (whichever is first), throughout the trial and for six months after the last administration of vemurafenib or cobimetinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception as in E, above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nExclusion Criteria:\n\nA. Diagnosis of unresectable or metastatic melanoma with a BRAF V600 mutation.\n\nB. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for six months following their last dose of vemurafenib or cobimetinib, whichever is later.\n\nC. Patients with QTcF (Corrected QT interval by Fridericia) at screening of \\>450 ms for males and \\>470 ms for females measured on triplicate ECG (if 1\u002F3 readings show \\>450\u002F470 ms then patient is ineligible).\n\nD. Patients with any history of long QT syndrome or Torsades de Pointes (or any concurrent medication with a known risk of inducing Torsades de Pointes).\n\nE. Known hypersensitivity to vemurafenib or cobimetinib or any of the excipients.\n\nF. Patients unable to swallow vemurafenib and cobimetinib intact, without chewing or crushing the tablets (as per the dosing schedule).\n\nG. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during vemurafenib and cobimetinib treatment or within six months after the final dose of vemurafenib and cobimetinib.\n\nH. Patients with clinically significant pre-existing cardiac conditions including (within the last three months prior to screening):\n\n* Uncontrolled or symptomatic angina,\n* Uncontrolled atrial or ventricular arrhythmias,\n* Class III \\& IV New York Heart Association congestive heart failure,\n* Left ventricular ejection fraction (LVEF) \\\u003C50%,\n* Myocardial infarction\n\nI. Ophthalmological disorders: History of retinal detachment, severe visual impairment, central serous chorioretinopathy, neovascular retinopathy, or retinopathy of prematurity.\n\nPatients with low grade gliomas causing visual impairment may be considered eligible and monitored with close ophthalmological monitoring.\n\nJ. History of pancreatitis.\n\nK. History of central nervous system (CNS) or gastrointestinal (GI) haemorrhage within three months of trial entry.\n\nL. Patients with any history of haemorrhagic stroke.\n\nM. Prior treatment with the same class of drug unless presence of a resistance alteration known to be potentially sensitive to either vemurafenib or cobimetinib. Prior sorafenib use is permissible following a washout period of 10 days.\n\nN. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nO. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of vemurafenib and cobimetinib, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome-associated opportunistic infection in the last 12 months.","18 Years",{"count":20,"type":21},[24,25],"This clinical trial is looking at a combination of drugs called vemurafenib and cobimetinib. Vemurafenib is approved as standard of care for adult patients with unresectable or metastatic melanoma. Cobimetinib is approved as standard of care in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nCobimetinib and vemurafenib work in patients with these types of cancers which have certain changes in the cancer cells called BRAF V600 mutation-positive.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which are also BRAF V600 mutation-positive. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[28,90,91,39,40,41,92,43,44,37,45,46],"Melanoma","Thyroid Cancer, Papillary","Carcinoma, Non-Small-Cell Lung",[48,49,36,52,53,54,55,31,32,58,94,59,61,95,96],"Cobimetinib","Tumour-agnostic","Vemurafenib","RECRUITING","2025-11-19",{"date":100,"type":69},"2025-11-24",{"date":102,"type":69},"2023-03-01",{"date":73,"type":21},{"name":75,"class":76},16,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100603572","taiwanese-anaplastic-thyroid-cancer-registry-100603572","NCT07138261","Taiwanese Anaplastic Thyroid Cancer Registry","TATC","Inclusion Criteria:\n\n1. Pathologically or cytologically confirmed ATC and diagnosed after 2015.\n2. Capable of understanding and complying with the protocol requirements and signed informed consent. The dead patient can be enrolled without signed informed consent and they were dead before 2025.6.30.\n\nExclusion Criteria:\n\n1. Inability and unwillingness to give informed consent except dead patient.\n2. Patients refuse for collection of clinical data and follow up.",{"count":114,"type":21},100,"OBSERVATIONAL","Primary treatment strategies for ATC have included surgical resection combined with radiotherapy, chemotherapy, or concurrent chemoradiation therapy. Despite these aggressive approaches, disease recurrence or progression remains frequently observed. Recent advances in molecular diagnostics and targeted therapy development have expanded treatment options for ATC patients with actionable genetic alterations, such as BRAF mutations or NTRK fusions. Nevertheless, for patients lacking identifiable targetable mutations, therapeutic options remain limited and clinical outcomes are poor. To address this unmet clinical need, the investigators aim to analyze baseline characteristics, treatment outcomes, and biomarker profiles from a larger cohort of ATC patients, with the goal of identification of predictive biomarkers and potential therapeutic targets. Given the rarity of ATC, conducting comprehensive studies at a single institution is challenging. Therefore, the investigators propose to establish a multi-center registry to systematically collect clinical data and tumor specimens from ATC patients.",[45],[119,120,121],"Anaplastic thyroid cancer","Genetic aberrations in anaplastic thyroid cancer","Treatment for anaplastic thyroid cancer","2025-08-17",{"date":124,"type":69},"2025-08-22",{"date":126,"type":21},"2025-09-01",{"date":128,"type":21},"2035-12-30",{"name":130,"class":76},"National Health Research Institutes, Taiwan",9]