[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-pancreatic-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-pancreatic-carcinoma":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,83,109,132,164,206],{"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":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100513775","phase-2-at-home-cancer-directed-therapy-versus-in-clinic-for-the-treatment-of-patients-with-advanced-cancer-100513775",false,"NCT05969860","At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer","Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic","Inclusion Criteria:\n\n* Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.\n\n  * Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:\n  * Eligible disease cancer types:\n\n    * Anal cancer\n    * Appendiceal carcinoma\n    * Basal cell carcinoma\n    * Bladder cancer\n    * Biliary cancer\n    * Breast cancer\n    * Central Nervous System malignancy including glioblastoma\n    * Cervical cancer\n    * Cholangiocarcinoma\n    * Colorectal carcinoma\n    * Endometrial cancer\n    * Fallopian tube cancer\n    * Gastroesophageal cancer \\[including gastric, esophageal, and gastroesophageal junction (GEJ) cancers\\]\n    * Germ cell carcinoma\n    * Head and Neck cancer\n    * Hepatocellular Carcinoma\n    * Liver\n    * Lung\n    * Lymphoma\n    * Melanoma\n    * Merkel Cell\n    * Multiple Myeloma\n    * Myelodysplastic syndrome\n    * Myeloid Disorders\n    * Neuroendocrine carcinoma\n    * Ovarian cancer\n    * Pancreatic adenocarcinoma\n    * Penile carcinoma\n    * Peritoneal carcinoma\n    * Prostate cancer\n    * Renal cell cancer\n    * Sarcoma\n    * Squamous cell Carcinoma of the Skin\n    * Testicular cancer\n    * Urethral carcinoma\n    * Vaginal carcinoma\n    * Vulvar carcinoma\n  * Eligible Regimens\n\n    * Fluorouracil (5-FU) +\u002F- leucovorin +\u002F- bevacizumab +\u002F- trastuzumab\n    * 5FU +\u002F- leucovorin +\u002F- bevacizumab +\u002F- nivolumab\n    * Atezolizumab +\u002F- bevacizumab\n    * Atezolizumab +\u002F- bevacizumab + cobimetinib, atezolizumab +\u002F- bevacizumab + vemurafenib, atezolizumab +\u002F- bevacizumab + cobimetinib + vemurafenib\n    * Avelumab\n    * Avelumab + axitinib\n    * Bevacizumab\n    * Bevacizumab + capecitabine\n    * Bevacizumab + irinotecan (+\u002F- capecitabine)\n    * Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib\n    * Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus\n    * Bevacizumab + trifluridine\u002Ftipiracil\n    * Bortezomib\n    * Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor\n    * Bortezomib + venetoclax\n    * Carfilzomib\n    * Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor\n    * Carfilzomib + venetoclax\n    * Cemiplimab\n    * Cisplatin\n    * Cisplatin\u002F5-FU\n    * Cisplatin\u002Fetoposide\n    * Cisplatin + durvalumab\n    * Cisplatin + gemcitabine\n    * Cisplatin + gemcitabine + durvalumab\n    * Daratumumab (+ oral \\[PO\\] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Degarelix\n    * Durvalumab\n    * Durvalumab + tremelimumab\n    * Eribulin\n    * FOLFIRI +\u002F- bevacizumab (5FU +\u002F- leucovorin + irinotecan)\n    * Fam-trastuzumab deruxtecan\n    * Fulvestrant\n    * Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib\n    * Gemcitabine\n    * Gemcitabine + durvalumab\n    * Gemcitabine + paclitaxel protein-bound\n    * Goserelin acetate\n    * Irinotecan\n    * Irinotecan + capecitabine\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + cabozantinib\n    * Nivolumab-relatlimab\n    * Octreotide\n    * Paclitaxel\n    * Pembrolizumab\n    * Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +\u002F- trametinib, pembrolizumab + trametinib)\n    * Pemetrexed\n    * Pertuzumab\n    * Pemetrexed + pembrolizumab\n    * Rituximab\n    * Trastuzumab + paclitaxel\n    * Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+\u002F- tucatinib +\u002F- capecitabine)\n    * Decitabine\n    * These regimens can be used only if patients are receiving one of the regimens above:\n\n      * Darbepoetin-alfa\n      * Epoetin\n      * Filgrastim\n* Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:\n\n  * Zoledronic acid\n  * Denosumab\n* Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent\n* Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.\n* Residing within the area serviced by supplier and paramedic network\n* Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution\n* Age \\>= 18 years at time of registration\n* Signed informed consent form by patient\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Ability to complete questionnaire(s) by themselves or with assistance\n* RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or palbociclib in combination with endocrine therapy (e.g., Leuprolide, fulvestrant intramuscular \\[IM\\], etc.); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma; temozolomide, lomustine, or afinitor in combination with avastin for glioblastoma. In addition, all oral anti-hormonal agents for breast and prostate cancer are permitted (e.g., tamoxifen, arimidex, abiraterone, etc.) if used in combination with any of the drugs\n* Requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction =\\\u003C 6 months\n  * Wound healing disorder\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","ALL","18 Years",{"count":19,"type":20},220,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69],"Advanced Anal Carcinoma","Advanced Biliary Tract Carcinoma","Advanced Bladder Carcinoma","Advanced Breast Carcinoma","Advanced Carcinoid Tumor","Advanced Cervical Carcinoma","Advanced Colorectal Carcinoma","Advanced Gastric Carcinoma","Advanced Glioblastoma","Advanced Head and Neck Carcinoma","Advanced HER2 Positive Breast Carcinoma","Advanced Lung Carcinoma","Advanced Lung Small Cell Carcinoma","Advanced Malignant Germ Cell Tumor","Advanced Malignant Solid Neoplasm","Advanced Neuroendocrine Carcinoma","Advanced Ovarian Carcinoma","Advanced Pancreatic Carcinoma","Advanced Prostate Small Cell Neuroendocrine Carcinoma","Advanced Prostate Carcinoma","Hematopoietic and Lymphoid System Neoplasm","Multiple Myeloma","Myelodysplastic Syndrome","Advanced Basal Cell Carcinoma","Advanced Cholangiocarcinoma","Advanced Endometrial Carcinoma","Advanced Esophageal Carcinoma","Advanced Fallopian Tube Carcinoma","Advanced Hepatocellular Carcinoma","Advanced Liver Carcinoma","Advanced Lymphoma","Advanced Malignant Testicular Neoplasm","Advanced Melanoma","Advanced Merkel Cell Carcinoma","Advanced Penile Carcinoma","Advanced Primary Malignant Central Nervous System Neoplasm","Advanced Renal Cell Carcinoma","Advanced Sarcoma","Advanced Skin Squamous Cell Carcinoma","Advanced Urethral Carcinoma","Advanced Vaginal Carcinoma","Advanced Vulvar Carcinoma","Advanced Appendix Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","RECRUITING","2026-04-15",{"date":73,"type":74},"2026-04-20","ACTUAL",{"date":76,"type":74},"2023-08-23",{"date":78,"type":20},"2027-01-01",{"name":80,"class":81},"Mayo Clinic","OTHER",2,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100585760","phase-2-a-phase-ii-nationwide-fully-decentralized-telemedicine-study-of-pemigatinib-in-adult-patients-with-advanced-or-metastatic-pancreatic-cancer-with-fgfr-genetic-alterations-100585760","NCT06906562","A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations","A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR2 Gene Fusions or Other FGFR Genetic Alterations","Inclusion Criteria\n\nPatients with histologically or cytologically confirmed advanced or metastatic pancreatic cancer of any histologic classification at the time of diagnosis\n\n* Written documentation of local or central Clinical Laboratory Improvement Act (CLIA)-certified laboratory determination of FGFR gene fusions\u002Ftranslocations or activating mutations\n* The study is open to pancreatic cancer in the following cohorts:\n\n  * Cohort 1: Pancreatic cancer of any histology with FGFR2 fusion\u002Ftranslocation (n, up to 30) who have progressed on or are intolerant to at least one standard of care (SOC) therapy. Prior therapy with a different FGFR inhibitor is not permitted. Patients with concurrent Kirsten rat sarcoma (KRAS) mutations are excluded from this cohort\n  * Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion\u002Ftranslocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications (n, up to 10). Patients must have progressed on or are intolerant to at least one SOC therapy. Prior therapy with a different FGFR inhibitor is not permitted. Patients with concurrent KRAS mutations are permitted in this cohort\n* Evidence of measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n* Patients must have received at least one prior SOC regimen for advanced\u002Fmetastatic pancreas cancer. Patients should have had evidence of progressive disease following their prior regimen, or if prior treatment was discontinued due to toxicity must have continued evidence of measurable or evaluable disease. Patients who have received prior treatment with an alternate FGFR inhibitor are not eligible for the study\n* Patients with symptomatic central nervous system (CNS) metastases are excluded (because it is unclear how much CNS penetration the drug has). However, asymptomatic patients with history of successfully treated CNS metastases with surgery or radiation and follow up imaging showing stability, can be eligible\n* Patients ≥ 18 years of age of either gender\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (patients with ECOG performance status of 2 may be considered on a case-by-case basis after discussion with Incyte)\n* Able to read and\u002For understand the details of the study and provide written evidence of informed consent as approved by Institutional Review Board (IRB)\u002FEthics Committee (EC)\n* Recovery from adverse events of previous systemic anti-cancer therapies to baseline or Grade 1, except for:\n\n  * Alopecia\n  * Stable neuropathy of ≤ Grade 2 due to prior cancer therapy\n* Able to swallow and retain oral medication\n* Willing and able to comply with scheduled visits, treatment plan and laboratory tests\n\nExclusion Criteria\n\n* Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids.\n\n  \\* Note: Steroid use for management of CNS tumors is allowed but must be at a stable dose for at least 2 weeks preceding study entry\n* History of another primary malignancy except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study or affect survival\n* Any other medical condition that would, in the investigator's , prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures\n* Current evidence of corneal or retinal disorder\u002Fkeratopathy including, but not limited to, bullous\u002Fband keratopathy, corneal abrasion, inflammation\u002Fulceration, keratoconjuctivitis, confirmed by ophthalmologic examination\n* History and\u002For current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral pemigatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)\n* Current evidence of endocrine alterations of calcium\u002Fphosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc.\n* Treatment with any of the following anti-cancer therapies prior to the first dose of pemigatinib within the stated timeframes:\n\n  * Cyclical chemotherapy (intravenous) within a period of time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C)\n  * Biological therapy (e.g., antibodies - including bevacizumab) within a period of time that is ≤ 5 t1\u002F2 or ≤ 4 weeks, whichever is shorter, prior to starting study drug\n  * Continuous or intermittent small molecule therapeutics within a period of time that is ≤ 5 t1\u002F2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug\n  * Any other investigational agents within a period of time that is ≤ 5 t1\u002F2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shortest) prior to starting study drug\n  * Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug\n* Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and\u002For calcium concentration are excluded. Patients are not permitted to receive enzyme-inducing anti-epileptic drugs\n* Consumption of grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, Seville oranges or products within 7 days prior to first dose\n* Absolute neutrophil count (ANC) ≤ 1,000\u002Fmm\\^3 \\[1.0 x 10\\^9\u002FL\\]\n* Platelets ≤ 75,000\u002Fmm\\^3 \\[75 x 10\\^9\u002FL\\] • Hemoglobin ≤ 9.0 g\u002FdL\n* Total bilirubin ≥ 1.5x upper limit of normal (ULN) unless associated with patient's primary cancer and\u002For metastases and with principal investigator's approval\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 3x ULN unless associated with patient's primary cancer and\u002For metastases and with principal investigator's approval\n* Alkaline phosphatase ≥ 2.5x ULN unless associated with patient's primary cancer and\u002For metastases and with principal investigator's approval\n* Calculated or measured creatinine clearance of \\\u003C 40 mL\u002Fmin\n* Calcium-phosphate homeostasis:\n\n  * Inorganic phosphorus outside of institutional normal limits\n  * Total serum calcium (can be corrected) outside of institutional normal limits\n* History of clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure, or arrhythmia requiring therapy. Subjects with a pacemaker and well-controlled rhythm for at least 1 month prior to first dose will be allowed\n* Pregnant or nursing (lactating) 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\n* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months following the discontinuation of study treatment. Highly effective contraception methods include:\n\n  * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment\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, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine systems (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), 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. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential\n* Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after the last dose of the study drug and should not father a child in this period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via seminal fluid",{"count":91,"type":20},40,[23],"This phase II study evaluates how well pemigatinib works for the treatment of adult patients with pancreatic cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started to other places in the body (metastatic) and that have abnormal changes (alterations) in the fibroblast growth factor receptor (FGFR) gene. FGFR genes are genes that, when altered, can lead to and promote the growth of cancer in patients. Researchers want to test if using pemigatinib can block the function of these abnormal FGFR genes and prevent the tumor from growing and whether treatment can help improve overall quality of life.",[43,95,96,97,98],"Metastatic Pancreatic Carcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","2026-02-12",{"date":101,"type":74},"2026-02-17",{"date":103,"type":74},"2025-08-26",{"date":105,"type":20},"2028-12-31",{"name":107,"class":81},"Sameek Roychowdhury",109,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100479704","austrian-registry-for-evaluation-of-treatment-patterns-and-outcome-in-patients-with-advanced-pancreatic-ductal-adenocarcinoma-pdac-100479704","NCT05526443","Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)","ADPACA","Inclusion Criteria:\n\n* 18 years, female and male\n* ECOG (Eastern Cooperative Oncology Group) Scale 0-2\n* Diagnosis of histologically confirmed locally advanced inoperable and\u002For metastatic PDAC\n* Patients undergoing palliative 1st line therapy with a platinum- or gemcitabine- based chemotherapy in case of previous (neo)adjuvant therapy also patients who receive nal-Irinotecan\u002F5-FU\u002FLeukovorin as palliative first line are eglible\n* Signed informed consent for prospective patients, for retrospective cases no informed consent is required\n\nExclusion Criteria:\n\n* Patients with locally advanced operable PDAC who do not receive palliative chemotherapy\n* Patients with locally advanced borderline resectable PDAC who do not receive palliative chemotherapy",{"count":117,"type":20},1500,"OBSERVATIONAL","To systematically collect and analyse real-world data on treatment patterns, clinical outcomes and toxicities among patients with advanced pancreatic ductal adenocarcinoma (PDAC) undergoing systematic treatment in Austria",[121,43],"Pancreatic Cancer","2025-11-18",{"date":124,"type":74},"2025-11-21",{"date":126,"type":74},"2023-01-13",{"date":128,"type":20},"2027-09",{"name":130,"class":81},"Medical University of Graz",12,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":163},"100497644","phase-1-first-in-human-phase-i-study-to-evaluate-safety-tolerability-and-antineoplastic-activity-of-oatd-02-in-patients-with-selected-advanced-andor-metastatic-solid-tumours-100497644","NCT05759923","First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced And\u002For Metastatic Solid Tumours","An Open-label, Multicentre, Dose-escalation, First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced And\u002For Metastatic Solid Tumours (colorectal Cancer, Ovarian Cancer, Pancreatic Cancer or Renal Cell Carcinoma)","Inclusion Criteria:\n\n1. Capable of understanding and complying with protocol requirements.\n2. Male or female patient aged ≥18 years at Screening.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Histologically or cytologically confirmed advanced and\u002For metastatic colorectal cancer, renal cell cancer, or pancreatic cancer or recurrent serous ovarian cancer (platinum-resistant\u002Fineligible to receive platinum-based chemotherapy), that either progressed or relapsed after all relevant standard of care cancer therapies (at least 1 line of systemic cancer therapy).\n5. Written informed consent given by the patient before the initiation of any study procedures.\n\nExclusion Criteria:\n\n1. Unable to take oral medications.\n2. Clinically active central nervous system metastases and\u002For carcinomatous meningitis.\n3. Major surgery within 30 days before the first IMP dose.\n4. Pregnant or breastfeeding women.\n5. Known allergy to excipients of the IMP.\n6. Severe, uncontrolled systemic disease which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to participate in the study.\n7. Participation in another clinical study within 4 weeks before the first IMP dose.",{"count":91,"type":20},[141],"PHASE1","The goal of this clinical trial is to learn if the OATD-02 administration (orally) in monotherapy is safe and has the pharmacodynamic potential to restore and enhance tumour responses to immunotherapy through increased arginine levels or intrinsic anti-tumour activity in participants with advanced metastatic colorectal cancer, ovarian cancer, renal cancer or pancreatic cancer.",[42,62,43,32,95,144,145,146],"Metastatic Colorectal Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Ovarian Carcinoma",[148,149,150,151,152],"solid tumors","renal cancer","ovarian cancer","pancreatic cancer","colorectal cancer","2025-02-20",{"date":155,"type":74},"2025-02-24",{"date":157,"type":74},"2023-01-26",{"date":159,"type":20},"2025-12",{"name":161,"class":162},"Molecure S.A.","INDUSTRY",3,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100495576","phase-2-cpi-613-devimistat-in-combination-with-hydroxychloroquine-and-5-fluorouracil-or-gemcitabine-in-treating-patients-with-advanced-chemorefractory-solid-tumors-100495576","NCT05733000","CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors","Phase II Open-Label Multi-Cohort Study Evaluating CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Patients With Advanced Chemorefractory Colorectal, Pancreatic, or Other Solid Cancers","Inclusion Criteria:\n\n* Patients must have histologically confirmed cancer for which standard-of-care curative measures are no longer effective or be intolerant to those agents. Patients in cohort 1 must have colorectal cancer. Patients in cohort 2 must have pancreatic cancer. Patients in cohort 3 may have any of the following cancers:\n\n  * Biliary\n  * Gastroesophageal\n  * Urothelial\n  * Ovarian\n  * Non-small cell lung (adenocarcinoma only)\n* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 disease.\n* Patients must have radiographic documentation of metastatic disease with imaging within =\\\u003C 6 weeks prior to registration.\n* Patients must be age \\>= 18 years.\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Performance Status of 2 will be allowed with approval from principle investigator (PI) on a case-by case basis.\n\n  * Note: Performance status of 2 will be allowed with approval from PI on a case-by case basis. Documentation of PI approval in these cases will be stored with inclusion\u002Fexclusion signed checklist for patient and\u002For in patient's shadow chart.\n* Patients must have exhausted all available molecularly targeted therapies (e.g., anti-PD-1\u002Fanti-PD-L1 agents where indicated).\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (within the last 14 days of screening)\n* Hemoglobin (Hgb) \\>= 9 g\u002FdL (within the last 14 days of screening) (Transfusions permitted. Eligibility labs should be drawn \\>= 7 days from transfusion).\n* Platelets (PLT) \\>= 100,000\u002FmcL (within the last 14 days of screening) (Transfusions permitted. Eligibility labs should be drawn \\>= 7 days from transfusion).\n* INR (international normalized ratio) =\\\u003C 1.6 (within the last 14 days of screening) (unless receiving anticoagulation therapy) If receiving anticoagulant: INR =\\\u003C 3.0 and no active bleeding, (i.e., no bleeding within 14 days prior to first dose of study therapy).\n* Total bilirubin =\\\u003C1.5 x Institutional upper limit of normal (ULN) (within the last 14 days of screening)\n\n  * Note: Patients with Gilbert's Syndrome are exempt. Patients with liver metastases with no significant bilirubin obstruction may have a total bilirubin level of =\\\u003C 2.0 mg\u002FdL.\n* Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) =\\\u003C 2.5 x institutional ULN (within the last 14 days of screening)\n\n  * Note: If liver metastases are present, then =\\\u003C 5 x ULN is allowed.\n* Alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT) =\\\u003C 2.5 x institutional ULN (within the last 14 days of screening)\n\n  * Note: If liver metastases are present, then =\\\u003C 5 x ULN is allowed.\n* Serum albumin \\> 3.0 g\u002FdL (within the last 14 days of screening)\n* Creatinine =\\\u003C 1.5 x ULN OR glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 (within the last 14 days of screening)\n\n  * eGFR is estimated GFR calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation\n* The effects of combination treatment of CPI-613, 5-FU, gemcitabine, and HCQ on the developing human fetus are unknown. For this reason and because antineoplastic agents as well as other therapeutic agents used in this trial are known to be teratogenic, patients of child-bearing potential (POCBP) regardless of gender must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 180 days following completion of therapy. Patients who can impregnate their partners regardless of gender must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 180 days following completion of therapy. Should a patient become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform their treating physician immediately.\n\n  * Note: At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n  * Note: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy\n    * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative pregnancy test prior to registration on study.\n\n  * Note: If negative pregnancy test result is \\>7 days from first dose of study treatment it must be repeated at time of first dose of study treatment (with any of the four drugs used in this study).\n* For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration.\n* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment, must have an undetectable HCV viral load. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. Patients must be class 2B or better.\n\n  * Note: Patients with pacemakers where corrected QT interval (QTc) is not a reliable measure will require an evaluation by a cardiologist to exclude co-existing cardiac conditions which would prohibit safe participation in the study.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document for the duration of the entirety of the study.\n* Patients must be reliable, willing to make themselves available for the duration of the entire study and willing to follow screening procedures.\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1).\n\n  * Note: Patients who experience adverse events of alopecia and peripheral neuropathy that have not recovered are eligible; patients with any lab abnormality that is above grade 1 related to previous therapy found to be not clinically significant will also be eligible.\n* Patients with symptomatic brain metastases currently using corticosteroids.\n\n  * Note: Patients with brain metastases who are asymptomatic and off corticosteroids for at least one week are eligible.\n* Patients with severe obstructive pulmonary disease or interstitial lung disease.\n* Patients with a history of myocardial infarction that is \\\u003C90 days prior to registration.\n* Patients using concomitant medications that prolong the QT\u002FQTc intervals. For example, patients receiving amiodarone. Using amiodarone together with hydroxychloroquine can increase the risk of long QT syndrome that although rare, may be serious, and potentially life-threatening.\n* Patients with a history of additional risk factors for drug-induced QT prolongation or Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT syndrome).\n* Patients with major surgery or significant traumatic injury =\\\u003C 21 days prior to registration.\n* Patients receiving treatment with low dose chemotherapy concurrent with radiation =\\\u003C 21 days prior to registration.\n\nOR patients who have had chemotherapy or radiotherapy =\\\u003C 21 days (42 days for nitrosoureas or mitomycin C) prior to registration.\n\n* Note: Palliative radiation before and during study participation is permissible providing it is not to a target lesion.\n\n  * Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:\n* Ongoing or active infection requiring systemic treatment.\n* Clinically significant complications such as perforation, gastrointestinal bleeding, or diverticulitis within 42 days prior to registration.\n* Symptomatic congestive heart failure; symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction.\n* Unstable angina pectoris.\n* Unstable cardiac arrhythmia.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active substance abuse.\n* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.\n\n  * Patients who are pregnant or nursing.\n  * Patients with Fridericia-corrected QT interval (QTcF) \\> 470 msec (female) or \\> 450 (male), or history of congenital long QT syndrome. Any electrocardiogram (ECG) abnormality that in the opinion of the investigator would preclude safe participation in the study.\n  * Patients who have pre-existing retinopathy of the eye.\n  * Patients who are unable to swallow or retain and absorb oral medication\n  * Patients with known hypersensitivity to any of the following: CPI or its inactive components, 4-aminoquinoline compounds, or quinine.\n  * Patients with poorly controlled diabetes mellitus (glycosylated hemoglobin (HbA1c) of \\> 7%, pre-prandial capillary plasma glucose \\> 130mg\u002Fdl, and peak postprandial capillary plasma glucose of \\> 180mg\u002Fdl).",{"count":172,"type":20},94,[23],"This phase II trial tests how well CPI-613 (devimistat) in combination with hydroxychloroquine (HCQ) and 5-fluorouracil (5-FU) or gemcitabine works in patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have not responded to chemotherapy medications (chemorefractory). Metabolism is how the cells in the body use molecules (carbohydrates, fats, and proteins) from food to get the energy they need to grow, reproduce and stay healthy. Tumor cells, however, do this process differently as they use more molecules (glucose, a type of carbohydrate) to make the energy they need to grow and spread. CPI-613 works by blocking the creation of the energy that tumor cells need to survive, grow in the body and make more tumor cells. When the energy production they need is blocked, the tumor cells can no longer survive. Hydroxychloroquine is a drug used to treat malaria and rheumatoid arthritis and may also improve the immune system in a way that tumors may be better controlled. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing abnormal cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. CPI-613 (devimistat) in combination with hydroxychloroquine and 5-fluorouracil or gemcitabine may work to better treat advanced solid tumors.",[27,32,69,176,40,42,43,177,178,179,180,144,181,182,146,95,183,184,185,186,187,188,189,190,96,191,192,193,97,194,195,196,98],"Advanced Lung Adenocarcinoma","Advanced Urothelial Carcinoma","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Metastatic Biliary Tract Carcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Lung Adenocarcinoma","Metastatic Urothelial Carcinoma","Refractory Biliary Tract Carcinoma","Refractory Colorectal Carcinoma","Refractory Gastroesophageal Junction Adenocarcinoma","Refractory Lung Adenocarcinoma","Refractory Ovarian Carcinoma","Refractory Pancreatic Carcinoma","Refractory Urothelial Carcinoma","Stage III Colorectal Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","2023-03-08",{"date":199,"type":74},"2023-03-10",{"date":197,"type":74},{"date":202,"type":20},"2030-03-04",{"name":204,"class":81},"Northwestern University",1,{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":216,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":205},"100486950","treatment-of-advanced-malignant-solid-tumors-with-claudin182car-t-100486950","NCT05620732","Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T","Efficacy and Safety of Claudin18.2CAR-T in Advanced Pancreatic Cancer and Gastric Carcinoma","Inclusion Criteria:\n\n1. Age 18-75 (≥ 18, ≤ 75), regardless of gender;\n2. Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;\n3. Non resectable, locally late recurrent or metastatic gastric cancer or pancreatic cancer confirmed by histopathology; Patients with gastric cancer or pancreatic cancer diagnosed as stage III or IV according to the TNM staging system of the American Joint Commission on Cancer (AJCC) (8th edition in 2017);\n4. According to RECIST 1.1 standard, there are clearly measurable and evaluable lesions;\n5. Immunohistochemical staining confirmed that Claudin 18.2 was moderately and highly expressed in tumor tissues;\n6. Subjects must have received the first and second line standard treatment scheme;\n7. The subject must not be suitable for receiving radical treatment methods, such as radical chemotherapy and radiotherapy and\u002For surgery\u002Fimmunosuppressant at the checkpoint, or refuse surgical resection\n8. Within 2 weeks before cell therapy, no antibody drugs were used;\n9. ECOG score is 0-2;\n10. The subjects had no contraindication for peripheral blood collection;\n11. The expected survival period is more than 3 months.\n\nExclusion Criteria:\n\n1. People who have a history of allergy to any component in cell products;\n2. The following conditions occur in blood routine examination: WBC ≤ 1 × 109\u002FL, absolute value of central granulocyte ANC ≤ 0.5 × 109\u002FL, absolute value of lymphocyte ALC ≤ 0.5 × 109\u002FL , PLT≦25 × 109\u002FL ；\n3. The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg\u002Fdl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg\u002Fdl;\n4. According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)\\\u003C50% by echocardiography;\n5. Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;\n6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;\n7. Grade 3 hypertension and poor blood pressure control after drug treatment;\n8. Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;\n9. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;\n10. There is uncontrolled active infection;\n11. Have used any CAR-T cell product or other genetically modified T cell therapy before;\n12. Live vaccine inoculation within 4 weeks before enrollment;\n13. HIV, HBV, HCV and TPPA\u002FRPR positive persons, and HBV carriers;\n14. Subjects have a history of alcohol abuse, drug abuse or mental illness;\n15. Subjects have participated in any other clinical research within 3 months before joining this clinical research;\n16. Female subjects have any of the following conditions: a) are in pregnancy\u002Flactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures;\n17. The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study","75 Years",{"count":215,"type":20},20,[217],"NA","The efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved. Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors.",[43,33],"2022-11-17",{"date":222,"type":74},"2022-11-22",{"date":224,"type":74},"2022-10-01",{"date":226,"type":20},"2028-10-31",{"name":228,"class":81},"Shenzhen University General Hospital"]