[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endometrial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endometrial":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100617415","phase-1-phase-ib-study-of-avutometinib-defactinib-and-everolimus-in-ras-pathway-mutant-endometrial-cancer-100617415",false,"NCT07318324","Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer","Eligibility Criteria\n\n1. Participants must have histologically or cytologically confirmed recurrent RAS mutant endometrial cancer. RAS pathway gene activating mutations include KRAS, NRAS, HRAS, BRAF, MEK1, and MEK2 activating mutations. Any endometrial histology is permitted, including endometrioid, clear cell, mesonephric, and serous.\n2. Participants must have received prior immune checkpoint inhibition treatment alone or in combination.\n3. Unlimited prior systemic therapies are permitted, including any number of prior MEK inhibitor regimens.\n4. Ability to understand and willingness to sign a written informed consent document.\n5. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n6. ECOG performance status of 0-1\n7. The effects of avutometinib and defactinib on the developing human fetus are unknown. For this reason, women of child-bearing potential must have a negative urine or serum pregnancy test within 72 hours of starting study and agree to use adequate contraception prior to study entry, for the duration of study participation, and for 3 months after the last dose of study drug. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n   * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   * History of hysterectomy or bilateral salpingo-oophorectomy.\n   * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n   The use of hormonal contraception methods is not recommended for this study. Approved methods of birth control are as follows: Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n8. Participants must have measurable disease as defined by RECIST v1.1\n9. Age ≥18 years.\n10. Participants must have adequate organ and marrow function as defined below:\n\n    absolute neutrophil count ≥1,000\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ 1.5x institutional ULN AST(SGOT)\u002FALT(SGPT) ≤3× institutional ULN creatinine clearance \\> 50 ml\u002Fmin hemoglobin \\> 9 g\u002FdL If a red blood cell transfusion or erythropoiesis-stimulating agent has been administered the hemoglobin must remain stable and ≥ 9 g\u002FdL for at least 1 week prior to first dose of study intervention.\n11. Creatine phosphokinase (CPK) ≤ 2.5 x ULN.\n12. Adequate cardiac function with left ventricular ejection fraction ≥ 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.\n\n    * QTc interval ≤ 460 ms using Fredericia's QT correction formula (at baseline from ECGs). NOTE: Participants with a right or left bundle branch block are allowed to have a QTc \\> 460ms.\n    * Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class I or II and stage A or B\n13. For dose expansion cohort: the participant must be willing to undergo biopsy procedure at screening and on treatment.\n\nExclusion Criteria\n\n1. Participants who are pregnant or lactating.\n2. Participants with sarcoma components of their endometrial cancer, except carcinosarcoma.\n3. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1.\n4. Participation in an interventional anti-cancer study (clinical trial) within 3 weeks prior to cycle 1 day 1\n5. Major surgery within four weeks before cycle 1 day 1.\n6. A history of congestive heart failure (CHF) of NYHA Class ≥3, or history of myocardial infarction (MI) within 3 months.\n7. Participants with a history of severe obstructive pulmonary disease, pulmonary hypertension, and\u002For pulmonary fibrosis in the opinion of treating MD\n8. History of medically significant rhabdomyolysis in the opinion of treating MD.\n9. For participants with prior MEK inhibitors, any history of or ongoing Grade 4 toxicity deemed related to MEK inhibitor\n10. Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; participants with controlled infection in the opinion of treating MD or on prophylactic antibiotics are permitted in the study.\n11. Activr Hepatitis B, or C infection as indicated by detectable viral load. Known HIV seropositivity with detectable viral load. Participants with an undetectable viral load are eligible for the trial.\n12. Any underlying condition that would significantly interfere with the absorption of an oral medication or inability to take oral medications in the opinion of treating MD\n13. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n14. Participants with symptomatic brain lesions\n15. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation). Subjects with known deep vein thrombosis\u002Fpulmonary embolism that are under appropriate anti-coagulation treatment are eligible\n16. History of clinically significant hemoptysis within 1 month prior to study enrollment for any tumor type.\n17. Current, non-healing wound, ulcer or bone fractures\n18. Known hypersensitivity to defactinib, avutometinib, everolimus, and\u002For other rapamycin derivatives.\n19. Current warfarin use. Participants who are being treated with warfarin within 7-14 days prior to enrollment for deep vein thrombosis\u002Fpulmonary embolism may be eligible if their warfarin therapy can be converted to low molecular weight heparin or direct oral anticoagulants (DOACs). Participants who can be transitioned should have INR checked after 5 days on low molecular weight heparin or a direct oral anticoagulant (DOAC).\n\n    Participants are eligible if the INR is ≤ 1.5 prior to the first study dose.\n20. Current use of medications (with or without prescriptions), supplements, herbal remedies, or foods (Grapefruit and grapefruit juice, Seville oranges and star fruit) with potential for drug-drug interactions with avutometinib and\u002For defactinib within 5 half-lives (if known), or if not known then 14 days prior to the first dose of study intervention, including:\n\n    * Strong CYP3A4 inhibitors or inducers\n    * Strong CYP2C9 inhibitors or inducers\n    * Strong P-glycoprotein (P-gp) inhibitors or inducers\n    * Strong breast cancer resistance protein (BCRP) inhibitors or inducers\n21. Specific concurrent ocular disorders:\n\n    * History of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes\n    * History of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mmHg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n    * Active or chronic, visually significant corneal disorders, other active ocular conditions requiring ongoing therapy, or clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy. Examples of visually significant corneal disorders include corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions. Visually significant corneal disorders do NOT include dry eyes, blepharitis, and uncomplicated corneal erosions.\n22. Severe skin disorder in the opinion of treating MD that has required systemic therapy within one year of the first dose of study intervention.","FEMALE","18 Years",{"count":18,"type":19},31,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","To find the recommended dose of the combination of avutometinib, defactinib, and everolimus in patients with endometrial cancer that is recurrent and has abnormal RAS activity. The safety and effects of this combination will also be studied.",[25,26,27,28],"Phase IB","Avutometinib","RAS Pathway","Endometrial","RECRUITING","2026-06-24",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2026-05-13",{"date":37,"type":19},"2030-08-01",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":20,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100607708","phase-2-clinical-trial-evaluating-the-activity-of-zanidatamab-for-the-treatment-of-patients-with-solid-tumors-with-an-alteration-of-the-her2-gene-100607708","NCT07192068","Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.","Widening Treatment Options Among Adult Patients With HER2-overexpressing or Mutant Solid Cancers.","AcSé HER2","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed endometrial, colorectal, head \\& neck, non-small cell lung cancer (NSCLC), or sarcoma\n2. Patient with progressive, unresectable and\u002For advanced or metastatic disease harboring a locally performed, centrally reviewed HER2-overexpressing (IHC 3+ exclusively) for endometrial, colorectal, head \\& neck cancers, or sarcoma or a HER2 activating mutation for NSCLC, determined on tissue (see Section 7.1.2 of the protocol)\n3. Age ≥ 18 years at inclusion\n4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n5. Patient who progressed at least after 1 line of therapy, for whom there is no other standard therapeutic option available\n6. Patient with a HER2 alteration covered by a standard marketed indication for any HER2 targeting therapy should be included after standard anti-HER2 strategy has been exhausted.\n7. Estimated life expectancy \\>3 months\n8. Measurable disease according to RECIST1.1, whatever the disease location. Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if progression has been clearly demonstrated in the lesion\n9. Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL, platelet count ≥75 × 10⁹\u002FL, and haemoglobin ≥9 g\u002FdL. Transfusion is allowed with a 2-week washout period before treatment initiation\n10. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (total bilirubin ≤3.0 ULN when the patient has documented Gilbert syndrome or liver metastasis), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 ULN when documented tumor liver involvement)\n11. Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 14 days before inclusion\n12. Normal prothrombin time (PT) \\>70% and partial thromboplastin time (PTT), except for patient who uses anticoagulants\n13. Adequate renal function: estimated serum creatinine clearance ≥ 30 mL\u002Fmin according to the Cockcroft-Gault formula\n14. Man, and woman of childbearing potential must agree to use highly effective contraception for the duration of trial participation and as required after completing study treatment (refer to Table 6 in the protocol). Man must also agree to not donate sperm and women must agree to not donate oocytes during the specified period\n15. Woman of childbearing potential must have a negative serum pregnancy test performed within 3 days before the date of treatment initiation\n16. Availability of a suitable archived FFPE sample of primary or metastatic tumor tissue (archived FFPE is \\\u003C2 years old (desirable), maximum 5 years (accepted), buffered formalin fixed only. Fine-needle aspiration (cytology samples) and biopsies from sites of bone metastases are not acceptable) or patient accepts an optional biopsy under study\n17. Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, specimen sampling for research, and other study procedures\n18. Affiliated to a social security system\n19. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent.\n\nExclusion Criteria:\n\n1. Patient, in the judgment of the investigator, who should be included in another recruiting study assessing an anti-HER2 therapy (including zanidatamab)\n2. Patient who received prior treatment with HER2-directed therapy unless marketed for the study cohort indication.\n3. Other primary malignancies within 3 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivor, who has undergone potentially curative therapy for a prior malignancy, has no evidence of that disease for 4 years or more and is deemed at negligible risk for recurrence, is eligible for the trial\n4. Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement not related to lung metastases (e.g. rheumatoid arthritis, Sjögren's syndrome, sarcoidosis)\n5. Prior pneumonectomy\n6. Patient with any condition or any evidence of severe or uncontrolled systemic diseases (e.g. active bleeding diatheses, active infection, or psychiatric illness) which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required for eligibility\n7. History of myocardial infarction or unstable angina within 6 months prior to enrolment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure\n8. Evidence of spinal cord compression or brain metastases, defined as being clinically active and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Patient with clinically inactive or treated brain metastases who are asymptomatic (i.e. without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Patient must have a stable neurologic status and no evidence of radiographic progression for at least 2 weeks prior to first zanidatamab dosing\n9. Patient with evidence of any leptomeningeal disease. If leptomeningeal disease has been reported radiographically on baseline magnetic resonance imaging (MRI), but is not suspected clinically by the investigator, the subject must be free of neurological symptoms.\n10. Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease\n11. Patient with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤1 or baseline, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Patient with chronic Grade 2 toxicities may be enrolled at the discretion of the investigator after consultation and approval by the coordinating investigator.\n12. Patient receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy within 2 weeks of first zanidatamab dosing unless otherwise approved by the coordinating investigator. Patient who requires use of bronchodilators, inhaled or topical or ocular steroids, or local steroid injections may be included in the study\n13. Treatment with anthracyclines within 90 days before first dose of zanidatamab and\u002For total lifetime load exceeding 360 mg\u002Fm2 doxorubicin or equivalent\n14. A history of life-threatening hypersensitivity to monoclonal antibodies or recombinant proteins\n15. Woman who is pregnant or breast-feeding\n16. Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable\n17. Patient unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n18. Individual deprived of liberty or placed under protective custody or guardianship.","ALL",{"count":52,"type":19},105,[54],"PHASE2","Alterations in the HER2 gene are involved in the development of cancer. These abnormalities are found at highly variable rates (from approximately 2% to 60%) in cancers of the lung, breast, stomach, bile ducts, salivary glands, colon, endometrium, uterus, bladder, bones, blood, etc. Zanidatamab is an anti-cancer drug that acts on cells with alterations in the HER2 gene. It is used in Europe to treat people with bile duct cancer.\n\nHowever, in various clinical trials, zanidatamab has shown promising activity in a few patients with different cancers that have a HER2 gene alteration. This treatment could therefore be effective in several types of cancer once this gene alteration is detected.\n\nThe primary objective is to evaluate the efficacy of zanidatamab in patients with cancer in one of the following locations: endometrium, colorectal, head and neck, sarcoma or lung cancer. Efficacy will be measured by the number of patients in whom a reduction in tumour size was observed.\n\nAll patients included in the study will receive zanidatamab by intravenous infusion every 3 weeks. Treatment will continue as long as there is a benefit (stabilisation or regression of the disease). During treatment, participants will visit the hospital regularly for medical consultations to:\n\n* assess and treat potential adverse effects of zanidatamab. A dose reduction may be applied to improve tolerance.\n* monitor disease progression using scans and\u002For MRI, performed every 6 weeks for the first 18 months of treatment and then every 12 weeks.\n\nAfter treatment is stopped (due to intolerance or disease progression), patients will be monitored according to hospital practices until the end of the trial, i.e. for 1 to 4 years, depending on when they were included in the clinical trial.",[57,58,59,60,28],"Non-Small Cell Lung Cancer","Sarcoma","Head &Amp; Neck Cancer","Colorectal Carcinoma",[62,63,64],"zanidatamab","HER2 mutant","HER2-IHC3+","2025-12-18",{"date":67,"type":33},"2025-12-19",{"date":69,"type":33},"2025-10-30",{"date":71,"type":19},"2030-06-24",{"name":73,"class":40},"UNICANCER",4,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":50,"minAge":16,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":20,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":41},"100583820","impact-of-prior-identification-and-education-of-patients-requiring-a-digestive-stoma-for-fecal-diversion-100583820","NCT06881303","Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion","RESTODIG","Inclusion Criteria:\n\n* Men or women aged 18 and over\n* for whom a fecal diversion stoma is planned on a scheduled or emergency basis\n* affiliated with the French social security system\n\nExclusion Criteria:\n\n* Patient in a period of exclusion from another research protocol at the time of signing the no-objection form,\n* Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),\n* No digestive stoma or fecal diversion planned\n* Person who does not understand French",{"count":83,"type":19},100,[85],"NA","There are many indications for performing a fecal diversion stoma. In both scheduled and emergency situations, and whatever the context (indication or type of fecal diversion stoma), stomal complications can occur early (10-60%) or late (25%), and may require repeat surgery. The most frequent complications are necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions, prolapse or eventration. What's more, a temporary stoma can become permanent.\n\nThe positioning and fabrication of the digestive stoma for fecal diversion must therefore comply with well-defined criteria to reduce the risk of stomal complications and the difficulties of fitting the stoma, and thus improve the autonomy and therefore the quality of life of the ostomate patient. The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively. What's more, the psychological impact of a stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and\u002For surgeons.\n\nThe impact of preoperative stoma identification and education on stoma complications, quality of life and patient autonomy has been reported in a few comparative series. The impact of preoperative education on quality of life has also been reported.\n\nHowever, despite this \"Evidence Based Medicine\", and the guide to good stoma therapy practice, the identification and education of the future fecal diversion stoma are not always carried out preoperatively. Reasons for this may include lack of time, lack of human resources, in the general context of a shrinking public hospital, or in the current context of distancing and dehumanization of the profession, or lack of conviction on the part of practitioners.\n\nTo this end, the investigators would like to propose a prospective observational study aimed at evaluating the impact of identification and education prior to the performance of a fecal diversion stoma in a programmed situation on the one hand, and an emergency situation on the other.\n\nThe main objective will be to compare quality of life specifically related to the stoma at 30 days postoperatively with the StomaQOL score, between 2 groups of patients:\n\n* unexposed group: no preoperative stoma identification and education\n* exposed group: preoperative stoma identification and education. This comparison will be stratified according to whether surgery is scheduled or emergency surgery.\n\nTotal 100 patients :\n\n* In scheduled surgery: 30 exposed and 30 unexposed patients\n* In emergency surgery: 10 exposed and 30 unexposed patients\n\nTimeline:\n\nInclusion period: 12 months Follow-up period: 12 months Total duration: 24 months",[88,28,89,90,91,92,93,94],"Colorectal Anastomosis","Anastomotic Leak Rectum","Ulcerative Colitis (Disorder)","Adenomatous Polyposis Coli, Familial","Crohn Disease","Digestive Cancers","Protectomy","NOT_YET_RECRUITING","2025-11-17",{"date":98,"type":33},"2025-11-18",{"date":100,"type":19},"2026-03-01",{"date":102,"type":19},"2028-03-01",{"name":104,"class":40},"Assistance Publique Hopitaux De Marseille"]