[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Toray Industries, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":103},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100519056","phase-2-a-study-of-trk-950-when-used-in-combination-with-ramucirumab-and-paclitaxel-in-patients-with-gastric-cancer-100519056",false,"NCT06038578","A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma.\n* The patient is eligible to receive Ramucirumab + Paclitaxel.\n* Documented objective radiographic or clinical disease progression (e.g., any new or worsening malignant effusion documented by ultrasound examination) which may be confirmed by pathologic criteria (histology and\u002For cytology) if appropriate, during or after treatment. The prior treatment must meet one of the following criteria with the following treatment history:\n\n  1. First treatment for metastatic disease or locally advanced disease without experiencing adjuvant \u002F neo-adjuvant treatment, which progressed during treatment or within 4 months after the last dose of treatment\n  2. Adjuvant \u002F neo-adjuvant treatment which progressed more than 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during the treatment or within 4 months after the last dose of treatment\n  3. Adjuvant \u002F neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment\n  4. Adjuvant \u002F neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during treatment or within 4 months after the last dose of treatment\n* Presence of primary or metastatic disease, measurable per RECIST v1.1 on CT scan.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 3 months.\n* Age ≥ 18 years in the US and Japan, and ≥ 19 years of age in Korea.\n* Signed, written IRB-approved informed consent.\n* Adequate organ function from specimens collected within 14 days prior to Day 1.\n* For men and women of child-producing potential, the use of effective contraceptive methods during the study and for 6 months after the last dose of TRK-950.\n* All patients must sign a pre-screening consent to assess tumor tissue to determine eligibility. Tumor tissue must be evaluable for CAPRIN-1 staining at a CLIA certified laboratory and meet or exceed the cutoff value (30% at ≥ 2+ staining) as defined in the expression level requirements.\n\nExclusion Criteria:\n\n* Prior history of treatment with ramucirumab or paclitaxel.\n* HER2 positive gastric or GEJ adenocarcinoma.\n* Major surgery within 28 days prior to randomization.\n* Baseline corrected QT (QTc) interval of \\> 470 msec for females and \\> 450 msec for males calculated using Fridericia's formula.\n* New York Heart Association (NYHA) Class II - IV symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia.\n* The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 3 months prior to randomization.\n* The patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Clinically symptomatic venous thromboembolism or current treatment with anti-coagulants. (Patients receiving prophylactic and low-dose anticoagulation therapy are eligible provided that the coagulation parameter defined in the Inclusion Criterion 9 is met.)\n* Uncontrolled arterial hypertension ≥ 150 mmHg (systolic) or ≥ 90 mmHg (diastolic) despite standard medical management.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n* Pregnant or nursing women.\n* Treatment with radiation therapy within 2 weeks, or treatment with chemotherapy, immunotherapy, targeted therapy, or investigational therapy within 4 weeks prior to randomization (within 2 weeks for Oral FU (S1 and capecitabine)).\n* The patient has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to randomization.\n* Clinically significant ascites, paracentesis in the last 3 months, or undergoes regular paracentesis procedures.\n* History of gastrointestinal perforation and\u002For fistulae within 6 months prior to randomization.\n* The patient has a serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.\n* The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (e.g., hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n* Known active infection with HIV, hepatitis B or hepatitis C. Patients with a history of hepatitis B or C are allowed if HBV DNA or Hep C RNA are undetectable.\n* The patient is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients who have recently discontinued dosing of study drug are eligible to participate as long as the final dose of study drug was ≥ 28 days from randomization for participation in this study. Patients participating in surveys or observational studies are eligible to participate in this study.","ALL","18 Years",{"count":19,"type":20},146,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study will assess the efficacy, safety, optimal dose and ADA and NAbs development of TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX) as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma.",[26,27,28],"Gastric Adenocarcinoma","Gastric Cancer","Gastroesophageal Junction Adenocarcinoma",[30,28,31,32],"Gastric Cancer, Adenocarcinoma","TRK-950","CAPRIN-1","RECRUITING","2026-06-18",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":37},"2023-10-04",{"date":41,"type":20},"2026-06-30",{"name":43,"class":44},"Toray Industries, Inc","INDUSTRY",27,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100471775","phase-1-a-study-of-trk-950-in-patients-with-advanced-solid-tumors-100471775","NCT05423262","A Study of TRK-950 in Patients With Advanced Solid Tumors","A Phase I\u002FII Study of TRK-950 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Part 1: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists. Part 2: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals.\n* Part 3: Patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists\n* Patients with life expectancy of at least 3 months after the start of study drug administration\n* Patients aged \\>=18 years at the time of consent\n* Patients who are able to provide written consent in person to be a subject of this study\n* A negative pregnancy test before enrollment (if female of childbearing potential)\n\nExclusion Criteria:\n\n* Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy\n* Pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed)\n* Patients who are unwilling or unable to comply with the protocol specified procedures\n* Patients who are positive for human immunodeficiency virus (HIV) antibody\n* Patients who meet any of the following conditions on hepatitis B virus (HBV) and hepatitis C virus (HCV) testing\n\n  * Patients who are positive for hepatitis B surface antigen (HBsAg)\n  * Patients who are positive for HCV RNA",{"count":54,"type":20},49,[56,23],"PHASE1","Part 1\n\n• To determine the safety and tolerability of TRK-950 in patients with advanced solid tumors\n\nPart 2\n\n• To determine the safety and tolerability of TRK-950 in combination with nivolumab(NIVO) in patients with advanced solid tumors eligible for NIVO therapy\n\nPart 3\n\n• To determine the efficacy of TRK-950 in patients with advanced\u002Frecurrent unresectable melanoma, who received prior chemotherapy with dacarbazine(DTIC) and for whom no standard therapy exists",[59,60],"Solid Tumor","Melanoma",[62,60],"Nivolumab-eligible solid tumor","2026-04-06",{"date":65,"type":37},"2026-04-13",{"date":67,"type":37},"2022-07-06",{"date":69,"type":20},"2027-12",{"name":43,"class":44},10,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100424288","pilot-clinical-study-of-noa-001-for-ards-acute-respiratory-distress-syndrome-100424288","NCT04804943","Pilot Clinical Study of NOA-001 for ARDS (Acute Respiratory Distress Syndrome)","Pilot Clinical Study to Investigate the Efficacy and Safety of NOA-001 for the Treatment of Patients With Acute Respiratory Distress Syndrome.","(ARDS caused by Non-COVID-19 cohort)\n\nInclusion Criteria:\n\nAt Informed Consent\n\n1. Patients with ARDS confirmed by the Berlin definition based on the following diagnostic criteria (a)-(d):\n\n   1. Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS.\n   2. Patients with respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e. g., echo-cardiography) to exclude hydrostatic edema if no risk factor present\n   3. Patients with bilateral opacities not fully explained by effusions, lobar\u002F lung collapse, or nodules on chest X-ray or CT scan\n   4. Patients with PaO2\u002F FiO2 ratio ≤ 300 mmHg (PEEP ≥ 5 cmH2O)\n2. Patients who are intubated and mechanically ventilated\n3. Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation\n4. Patients aged ≥ 16 years at informed consent (Signed informed consent form from legally acceptable representative must be available if patient is aged \\\u003C 20 years)\n\nAt Enrollment\n\n1. Patients with PaO2\u002F FiO2 ratio ≥ 50 mmHg and ≤ 200 mmHg (PEEP ≥ 5 cmH2O)\n2. Patients with bilateral opacities not fully explained by effusions, lobar\u002F lung collapse, or nodules on CT scan within 48 hours before enrollment\n3. Patients who are intubated and mechanically ventilated\n4. Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation\n\nExclusion Criteria:\n\nAt Informed Consent\n\n1. Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation\n2. Patients who are treated with ECMO or HFOV\n3. Patients with renal dialysis therapy for chronic renal failure\n4. Patients with congestive heart failure (NYHA class IV)\n5. Patients with acuter left ventricular failure\n6. Patients with liver failure (Child-Pugh grade C)\n7. Patients who have burns in excess of 15% total body surface area\n8. Patients after resuscitation from cardiac arrest\n9. Patients with a history of hypersensitivity to the anticoagulants (Heparin or Nafamostat mesylate)\n10. Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy within 7 days prior to informed consent\n11. Patients with pregnancy or lactating\n12. Patients tested positive for COVID-19\n\nAt Enrollment\n\n1. Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation\n2. Patients who are treated with ECMO or HFOV after obtaining informed consent prior to enrollment\n3. Patients with platelet count ≤ 50,000 \u002Fmm3 by the latest blood test\n4. Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy between informed consent and enrollment\n5. Patients whose life expectancy is ≤ 24 hours after enrollment\n6. Patients after resuscitation from cardiac arrest between informed consent and enrollment\n7. Patients tested positive for COVID-19 between informed consent and enrollment\n\n(ARDS caused by COVID-19 cohort)\n\nInclusion Criteria:\n\nAt Informed Consent\n\n1. Patients tested positive for COVID-19\n2. Patients with ARDS confirmed by the Berlin definition based on the following diagnostic criteria (a)-(d):\n\n   1. Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS.\n   2. Patients with respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e. g., echo-cardiography) to exclude hydrostatic edema if no risk factor present\n   3. Patients with bilateral opacities not fully explained by effusions, lobar\u002F lung collapse, or nodules on chest X-ray or CT scan\n   4. Patients with PaO2\u002F FiO2 ratio ≤ 300 mmHg (PEEP ≥ 5 cmH2O)\n3. Patients who are intubated and mechanically ventilated\n4. Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation\n5. Patients aged ≥ 16 years at informed consent (Signed informed consent form from legally acceptable representative must be available if patient is aged \\\u003C 20 years)\n\nAt Enrollment\n\n1. Patients with PaO2\u002F FiO2 ratio ≥ 50 mmHg and ≤ 200 mmHg (PEEP ≥ 5 cmH2O)\n2. Patients who are intubated and mechanically ventilated\n3. Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation\n\nExclusion Criteria:\n\nAt Informed Consent\n\n1. Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation\n2. Patients who are treated with ECMO or HFOV\n3. Patients with renal dialysis therapy for chronic renal failure\n4. Patients with congestive heart failure (NYHA class IV)\n5. Patients with acuter left ventricular failure\n6. Patients with liver failure (Child-Pugh grade C)\n7. Patients who have burns in excess of 15% total body surface area\n8. Patients after resuscitation from cardiac arrest\n9. Patients with a history of hypersensitivity to the anticoagulants (Heparin or Nafamostat mesylate)\n10. Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy within 7 days prior to informed consent\n11. Patients with pregnancy or lactating\n\nAt Enrollment\n\n1. Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation\n2. Patients who are treated with ECMO or HFOV after obtaining informed consent prior to enrollment\n3. Patients with platelet count ≤ 50,000 \u002Fmm3 by the latest blood test\n4. Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy between informed consent and enrollment\n5. Patients whose life expectancy is ≤ 24 hours after enrollment\n6. Patients after resuscitation from cardiac arrest between informed consent and enrollment","16 Years",{"count":81,"type":20},45,[83],"NA","The primary object of this clinical study is to investigate the efficacy and the safety of NOA-001 in patients with ARDS (ARDS caused by Non-COVID-19 or COVID-19).",[86],"Acute Respiratory Distress Syndrome",[88,89,90,86,91,92,93],"COVID-19","Diffuse Alveolar Damage","DAD","ARDS","NOA-001","Hemoperfusion","2024-07-08",{"date":96,"type":37},"2024-07-09",{"date":98,"type":37},"2021-05-22",{"date":100,"type":20},"2025-09-04",{"name":43,"class":44},1,""]