[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-pancreatic-ductal-adenocarcinoma-pdac\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-pancreatic-ductal-adenocarcinoma-pdac":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,83],{"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":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100642407","phase-1-phase-i-study-of-jfi447-68gaga-dfc413-and-comparison-to-ffg233-68gaga-nns309-in-patients-with-solid-tumors-100642407",false,"NCT07630961","Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Phase I, Open Label First in Human Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of JFI447 [68Ga]Ga-DFC413, and Compare to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Age ≥ 18 years old.\n3. ECOG performance status ≤ 2.\n4. Patients with one of the following indications (regardless of lines of prior therapy):\n\n   Locally advanced unresectable or metastatic PDAC, NSCLC, HR+\u002FHER2- ductal or lobular BC, TNBC, CRC or STS.\n5. Patients must have at least one measurable lesion per RECIST v1.1 as measured by local Investigator (by conventional MRI or CT scan).\n6. Patients must have an available archival tumor sample at the screening visit. If multiple archival tumor samples are available, the most recent will be requested. Exceptions may be made after documented discussion with Novartis.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Out-of-range laboratory values defined as:\n\n   * Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin (calculated using CKD-EPI 2021 formula, or measured based on 24-hour urine collection)\n   * Total bilirubin \\> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 x ULN) or direct bilirubin \\> 1.5 x ULN\n   * Alanine aminotransferase (ALT) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \\> 5.0 x ULN\n   * Aspartate aminotransferase (AST) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \\> 5.0 x ULN\n   * Absolute Neutrophil Count \\\u003C 1.0 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Platelet count \\\u003C 75 x 109\u002FL\n2. Unmanageable urinary tract obstruction or urinary incontinence. If ureteral obstruction can be managed with the placement of ureteral stents, this exclusion criterion does not apply.\n3. Known hypersensitivity to 68Ga-DFC413 or 68Ga-NNS309 or their excipients.\n4. Any serious uncontrolled infection (acute or chronic), such as, but not limited to, bacterial, viral or fungal infections, confirmed by clinical evidence, imaging, and\u002For relevant positive laboratory tests (e.g., blood cultures, PCR for DNA\u002FRNA). If a serious infection develops, it must resolve or be adequately controlled prior to 68Ga-DFC413 and\u002For 68Ga-NNS309 initiation.\n5. Surgery or major invasive procedure within 4 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n6. Radiation therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n7. Change in anticancer therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n8. Radiological contrast administration within 48 hours prior to 68Ga-DFC413 or 68Ga-NNS309 administration.\n9. Initiation or increasing doses of corticosteroids, TGF-β signaling inhibitors or immunomodulators within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n10. Known additional malignancy that is progressing or requires active treatment.\n11. Inability to complete the required investigational and standard imaging examinations due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time).\n12. Presence of CTCAE version 5.0 ≥ Grade 2 toxicity due to prior cancer therapy, except for neuropathy (inclusion of patients with neuropathy of ≤ Grade 2 is permitted) and alopecia.\n13. Any medical condition that would, in the Investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures (including radiation safety precautions), or interpretation of study results.\n14. Pregnant women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.\n15. Nursing (breast-feeding) women. Women who do not breast feed for 12 hours after 68Ga-DFC413 and\u002For 68Ga-NNS309 administration, but express and discard breast milk, are eligible.\n16. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they use highly effective methods of contraception (failure rate \\\u003C1% per year) for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309.\n\n    Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. hormonal profile confirming menopause and\u002For age-appropriate history of vasomotor symptoms).\n\n    Highly effective contraception methods include:\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Bilateral tubal ligation, female sterilization (have had bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking 68Ga-DFC413 or 68Ga-NNS309. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.\n    * Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.\n    * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example, hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n\n    If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent (IC).\n17. Sexually active males unwilling to use a condom during intercourse for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309. A condom is required for all sexually active male patients to prevent them from fathering a child and\u002For to prevent delivery of study treatment via seminal fluid to their partner. In addition, male patients must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the IC.\n\nOther protocol-defined inclusion\u002Fexclusioncriteria may apply.","ALL","18 Years",{"count":19,"type":20},66,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of \\[68Ga\\]Ga-DFC413, and in Part 2 compare to \\[68Ga\\]Ga-NNS309 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+\u002FHER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of \\[68Ga\\]Ga-DFC413 and \\[68Ga\\]Ga-NNS309), not all indications might be explored.",[26,27,28,29,30,31,32],"Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","Non-small Cell Lung Cancer (NSCLC)","HR+\u002FHER2- Ductal Breast Cancer (BC)","HR+\u002FHER2- Lobular Breast Cancer (BC)","Triple Negative Breast Cancer (TNBC)","Colorectal Cancer (CRC)","Soft Tissue Sarcoma (STS)",[34,35,36,37,38,39,40,41],"metastatic pancreatic ductal adenocarcinoma (PDAC)","non-small cell lung cancer (NSCLC)","HR+\u002FHER2- ductal breast cancer (BC)","HR+\u002FHER2- lobular breast cancer (BC)","triple negative breast cancer (TNBC)","colorectal cancer (CRC)","soft tissue sarcoma (STS)","radioligand imaging","RECRUITING","2026-07-27",{"date":45,"type":46},"2026-07-28","ACTUAL",{"date":48,"type":46},"2026-06-23",{"date":50,"type":20},"2028-01-16",{"name":52,"class":53},"Novartis Pharmaceuticals","INDUSTRY",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":64,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100648609","hellenic-evaluation-of-the-long-term-safety-and-efficacy-of-nalirifox-as-a-1st-line-therapy-in-metastatic-pancreatic-ductal-adenocarcinoma-mpdac-100648609","NCT07723261","Hellenic Evaluation of the Long-Term Safety and Efficacy of NalIriFOx as a 1st-line Therapy in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)","HELIOS","Inclusion Criteria:\n\n* Patients with histologically or cytologically proven metastatic PDAC\n* 1st line treatment with NalIriFOx according to physician's choice\n* Patients willing to provide a Written Informed Consent\n\nExclusion Criteria:\n\n* Patients not matching the above-mentioned inclusion criteria\n* Neoadjuvant or adjuvant treatment within 6 months from enrolment\n* Prior treatment with Liposomal irinotecan\n* Prior treatment of pancreatic cancer in the metastatic setting with chemotherapy or investigational therapy",{"count":63,"type":20},70,"12 Months","OBSERVATIONAL","This is multicenter, prospective, open label, non-interventional study that will collect real-world data (RWD) on the clinical efficacy and safety of NalIriFOx as a first-line therapy in metastatic pancreatic ductal adenocarcinoma (mPDAC).",[26],[69,70,71],"mPDAC","NalIriFOx","safety","2026-07-23",{"date":74,"type":46},"2026-07-24",{"date":76,"type":46},"2026-03-30",{"date":78,"type":20},"2029-03-30",{"name":80,"class":81},"Hellenic Cooperative Oncology Group","OTHER",9,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100647736","phase-2-a-study-comparing-whole-body-heat-treatment-plus-systemic-therapy-to-systemic-therapy-alone-for-advanced-pancreatic-cancer-100647736","NCT07711067","A Study Comparing Whole-Body Heat Treatment Plus Systemic Therapy to Systemic Therapy Alone, for Advanced Pancreatic Cancer","A Multi-Centric, Randomized, Pivotal Study, Evaluating Efficacy and Safety of Whole-Body Hyperthermia Alongside Standard Systemic Anticancer Therapy in Patients With Metastatic Pancreatic Cancer After Failure of First Line Treatment.","MATTERS-2","Inclusion Criteria:\n\n1. Subjects at least 18 years of age at time of signing the informed consent\n2. Subjects with metastatic pancreatic adenocarcinoma (PDAC) confirmed by histology\n3. Measurable disease per RECIST 1.1\n4. Subjects previously treated with chemotherapy in first line for metastatic disease\n5. ECOG performance status ≤ 1\n6. Height ≤ 2,00 m, BMI maximal 40 or positive fitting session\n7. Adequate liver structure (accessible metastasis-free and functional liver parenchyma) allowing stable liver sensor positioning without unacceptable risks of bleeding and perforation, based on echographic assessment (or any imaging modality)\n8. Adequate bone marrow function defined as\n\n   1. white blood cell count ≥ 2000\u002Fµl\n   2. neutrophils ≥ 1500 cells\u002FμL\n   3. platelets ≥ 100 x 109\u002FL\n   4. hemoglobin ≥ 9 g\u002Fdl (female) and ≥10 g\u002Fdl (male) documented\n9. Adequate coagulation defined as\n\n   1. PT (%) ≥ 70%\n   2. aPTT ≤ ULN\n10. Adequate liver function defined as\n\n    1. Transaminases (AST, ALT) ≤ 2.5 x ULN or ≤ 5.0 in presence of liver metastasis\n    2. bilirubin ≤ 2 x ULN\n11. Adequate renal function defined as calculated eGFR ≥ 60 mL\u002Fmin (CKD-EPI equation)\n12. Normal ionogram\n13. Effective contraception for both male and female subjects if applicable. Women of childbearing potential must have a negative pregnancy test at screening visit.\n14. Written informed consent must be given according to good clinical practice and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women\n2. Presence of brain metastasis (known or suspected)\n3. Other malignant diseases in the medical history during the last 5 years (exceptions: carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin)\n4. Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk defined as recent major cardiovascular events (such as myocardial infarction or stroke), clinically relevant heart failure due to structural or mechanical cardiac abnormalities (e.g., valvular disease or myocardial dysfunction), and clinically significant arrhythmias.\n5. Pathology that would interfere with the placement of the bladder catheter\n6. Clinically significant pulmonary disease which might interfere with mechanical ventilation\n7. History of autonomic dysfunction (due to the influence on skin blood flow)\n8. History of malignant hyperthermia\n9. History of untreated endocrine pathology (e.g. diabetes type II, hyper- or hypothyroidism).\n10. Primary untreated diabetes type I not related to the oncological condition (due to vascular complications).\n11. Known allergies to drugs that will be used during the trial (e.g. anesthetic, analgesic, chemotherapy)\n12. Active infections not controlled by medication\n13. Presence of clinically significant ascites and\u002For decompensated cirrhosis\u002Fportal hypertension\n14. Severe, non-healing wounds, ulcers or bone fractures\n15. Organ allografts requiring immunosuppressive therapy\n16. Implants that are not compatible with temperature changes\n17. (History of) clinically significant (investigator decision) psychiatric disorder and\u002For psychosocial disorder that may interfere with adequate compliance to the protocol or signature of the informed consent\n18. Other clinically significant disease which could impair the subject's ability to participate in the study according to the investigator's opinion\n19. Participation in another clinical trial 2 weeks prior to the randomization\n20. Biological therapy during the 2 weeks prior to the randomization\n21. Radiotherapy up to 2 weeks prior to the randomization\n22. Major surgery up to 6 weeks prior to the randomization (port-a-cath placement is minor)",{"count":92,"type":20},95,[94,95],"PHASE2","PHASE3","Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis and limited treatment options following failure of first-line therapy. Whole-body hyperthermia (WBHT) is a non-invasive treatment approach that raises the body's core temperature under controlled conditions and may enhance the effects of anticancer therapies through multiple biological mechanisms, including improved drug delivery, modulation of the immune response, and increased sensitivity to treatment.\n\nThe MATTERS-2 study is a multicentre, randomized clinical trial designed to evaluate the efficacy and safety of WBHT in combination with standard systemic anticancer therapy in patients with metastatic PDAC after failure of first-line treatment. Participants will receive either standard systemic therapy alone or standard systemic therapy combined with WBHT.\n\nThe primary objective of the study is to determine whether the addition of WBHT improves clinical outcomes compared with standard therapy alone in terms of overall survival (OS) while maintaining safety. Secondary objectives include other clinical outcomes such as progression-free survival (PFS), disease control rate (DCR) and objective response rate (ORR). Further, quality of life assessments (QoL) and exploratory biomarker analyses will also be performed.",[98,26],"Pancreatic Ductal Adenocarcinoma (mPDAC)",[100,101],"Hyperthermia","Medical device","NOT_YET_RECRUITING","2026-07-14",{"date":105,"type":46},"2026-07-17",{"date":107,"type":20},"2026-10-01",{"date":109,"type":20},"2030-12-31",{"name":111,"class":53},"ElmediX",4]