[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ono Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":415},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,41,67,97,120,143,165,187,210,238,260,282,302,335,357,377,395],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100625948","phase-3-intrepid-a-study-of-sapablursen-evaluating-the-safety-and-efficacy-in-participants-with-polycythemia-vera-pv-100625948",false,"NCT07429266","INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)","A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera","INTREPID","Inclusion Criteria:\n\n1. Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.\n2. Participants must be phlebotomy-dependent.\n3. Hct less than (\\\u003C) 45% at study start.\n4. Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start.\n5. Adequate organ function and electrolytes.\n\nExclusion Criteria:\n\n1. Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics.\n2. Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization.\n3. Participants who require phlebotomy at Hct levels \\\u003C45%.\n4. Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.\n5. Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of sapablursen when added on to current standard of care (SOC) for Polycythemia Vera (PV) therapy. The study will be conducted in three sequential parts (Part 1a blinded treatment, Part 1b open-label treatment, \\& Part 2 long-term extension). Participants may receive treatment for up to 156 weeks.",[27],"Polycythemia Vera","RECRUITING","2026-08-18",{"date":31,"type":32},"2026-08-20","ACTUAL",{"date":34,"type":32},"2026-05-25",{"date":36,"type":21},"2031-01",{"name":38,"class":39},"Ono Pharmaceutical Co., Ltd.","INDUSTRY",8,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100600941","phase-3-ignite-study-of-tirabrutinib-vs-rituximabtemozolomide-for-relapsedrefractory-primary-central-nervous-system-lymphoma-pcnsl-100600941","NCT07104032","IGNITE: Study of Tirabrutinib vs Rituximab\u002FTemozolomide for Relapsed\u002FRefractory Primary Central Nervous System Lymphoma (PCNSL)","A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed\u002FRefractory Primary Central Nervous System Lymphoma","IGNITE","Inclusion Criteria\n\n1. Pathology report confirming the diagnosis of B-cell PCNSL\n2. Relapsed or refractory B-cell PCNSL with at least 1 prior high-dose methotrexate (HD-MTX) based therapy for PCNSL:\n\n   * Relapsed disease: Participants who achieved a response (CR, CRu, PR) to the last treatment and subsequently experienced disease progression.\n   * Refractory disease: Participants whose best response to the last treatment was stable disease or PD.\n3. One or more bi-dimensionally measurable brain lesions with a minimum diameter greater than or equal to (≥)1 centimeter (cm) × ≥1 cm in gadolinium-enhanced magnetic resonance imaging (MRI)\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2\n5. Adequate bone marrow, renal, and hepatic function per central lab values\n6. Participants must agree to comply with all defined contraceptive requirements\n\nExclusion Criteria\n\n1. Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions\n2. Participants with non-B-cell PCNSL\n3. Participants with systemic presence of lymphoma\n4. Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment\n5. Concomitant systemic corticosteroid exposure within 14 days before starting study drug per Investigator assessment with the exception of the following:\n\n   * Equivalent of up to 10 milligram per day (mg\u002Fday) of prednisone for a disease other than PCNSL\n   * Equivalent of up to 50 mg\u002Fday of prednisone (equal to 8 mg\u002Fday dexamethasone) for participants with lesions of the brain and\u002For spinal cord\n6. Active malignancy, other than PCNSL requiring systemic therapy\n7. Poorly controlled comorbidity, or history of medical conditions contraindicated per Investigator assessment\n8. Participants who are unable to swallow oral medication\n9. Prior Bruton's tyrosine kinase inhibitor treatment",{"count":50,"type":21},132,[24],"The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed\u002FRefractory Primary Central Nervous System Lymphoma (PCNSL).",[54],"Relapsed\u002FRefractory Primary Central Nervous System Lymphoma",[56,47,57,58,54],"Bruton's tyrosine kinase (BTK)","PCNSL","Primary Central Nervous System Lymphoma","2026-08-16",{"date":29,"type":32},{"date":62,"type":32},"2026-06-12",{"date":64,"type":21},"2029-12",{"name":38,"class":39},32,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100650558","phase-1-a-study-to-investigate-the-safety-tolerability-and-pharmacokinetics-of-ono-6414-administered-orally-in-healthy-adult-participants-and-patients-with-active-ulcerative-colitis-100650558","NCT07749768","A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative Colitis","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally as Single Ascending Doses With a Food-Effect Arm and Multiple Ascending Doses in Healthy Adult Participants, and as a Single Dose (Open-Label) in Patients With Active Ulcerative Colitis","●Inclusion Criteria: \\\u003CHealthy Volunteers only\\>\n\n* Male or female, age ≥18- to ≤55-year-old at the time of signing ICF.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, 12-lead ECG, vital signs measurements, and laboratory tests results, as evaluated by the investigator.\n* BMI of 18.0 to 32.0 kg\u002Fm2, inclusive, and a body weight of ≥50 kg at Screening.\n\n\\\u003CPatients only\\>\n\n* Male or female, age ≥18-year-old at the time of signing ICF.\n* A diagnosis of ulcerative colitis (UC) must have been established at least three months prior to screening.\n\n\\\u003CHealthy Volunteers and Patients\\>\n\n* Total abstinence, in accordance with the lifestyle of the participant, from at least 30 days prior to the first dose until at least 90 days after the last dose.\n* Ability to understand the study procedures described in the ICF. Willingness and ability to comply with the protocol, and provides written informed consent prior to study participation.\n* Willingness and ability to swallow study intervention tablets and\u002For suspension.\n* Willing to take off dentures or mouth piercing at the time of dosing.\n\n  ●Exclusion Criteria: \\\u003CHealthy Volunteers only\\>\n* Mentally or legally incapacitated.\n* History or presence of clinically significant medical, surgical or psychiatric condition or disease that in the opinion of the investigator or medical monitor might confound the results of the study or pose an additional risk to the participant by their participation in the study, including but not limited to a history of inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding; history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection or history or clinical evidence of pancreatic injury or pancreatitis, history of cardiac arrhythmia (both atrial and ventricular). History of uncomplicated appendectomy and uncomplicated cholecystectomy are allowed.\n* History of any major invasive surgery within 6 months before the first dosing, or minor invasive surgery within 7 days before the first dosing.\n* History of hypersensitivity or idiosyncratic reaction to the study interventions, excipients (including Lactose) or related compounds, or severe food allergies.\n* History of rare hereditary galactose and\u002For Lactose intolerance (eg, congenital lactase deficiency \\[CLD\\] or glucose-galactose malabsorption \\[GGM\\]).\n* History or presence of alcoholism within 6 months before the first dosing. Alcohol abuse is defined as 7 or more drinks per week for a woman or 14 or more drinks per week for a man.\n* History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \\[PCP\\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.\n* Presence of recurring gastrointestinal symptoms (diarrhea, constipation, nausea, heartburn, etc.).\n* Presence of acute gastrointestinal symptoms within 7 days before the first dosing.\n* Use of medications for the timeframes and throughout the study (unless specified), with the exception of hormonal contraceptives and medications exempted by the investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study intervention or participant safety (eg, topical drug products without significant systemic absorption).\n\n\\\u003CPatients only\\>\n\n* Current diagnosis of indeterminate colitis, inflammatory bowel disease-unclassified, Crohn's disease, infectious colitis, or ischaemic colitis.\n* Evidence of fulminant colitis or ASUC at Screening.\n* The patient meets the following criteria:\n\n  * Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy for UC\n  * Evidence of abdominal abscess or toxic megacolon during Screening\n  * Imminent need for surgery or with elective surgery scheduled to occur during the study\n* Positive Clostridium difficile toxin test during Screening. However, re-screening can be undertaken following successful treatment.\n* Complications or history of immunologic, autoimmune or chronic inflammatory disorders (eg, uveitis, rheumatoid arthritis, ankylosing spondylitis or spondyloarthritis, psoriasis) other than UC.\n* Any evidence of colonic dysplasia, adenomas or polyposis. Those that have been completely resected can be included.\n* Mentally or legally incapacitated.\n* A history of malignant neoplasm within the last 5 years, except for adequately treated non-metastatic basal or squamous cell cancers of the skin (within 1 year) or carcinoma in situ of the uterine cervix (within 3 years) that has been fully treated and shows no evidence of recurrence.\n* History of hypersensitivity or idiosyncratic reaction to the study interventions, excipients (including Lactose) or related compounds, or severe food allergies.\n* History or presence of alcoholism within 6 months before the first dosing. Alcohol abuse is defined as 7 or more drinks per week for a woman or 14 or more drinks per week for a man.\n* History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \\[PCP\\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.\n* Previously untreated UC.\n* Initiation or change in the dose of the following medicines; oral sulfasalazine, aminosalicylate, oral or rectal corticosteroid, ciclosporin, mercaptopurine, azathioprine, methotrexate, anti-TNF biologic, anti-integrin, anti-IL-12\u002F23, anti IL-23 biologics, JAK inhibitor, or S1P1 modulator.\n* Fecal microbiota transplantation within 4 weeks prior to baseline endoscopy.\n* Use of medications for the timeframes specified below and throughout the study (unless specified), with the exception of hormonal contraceptives and medications exempted by the investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study intervention or participant safety (eg, topical drug products without significant systemic absorption):\n\n  * depot injection or implant within 3 months prior to dosing;\n  * live attenuated vaccines within 1 month prior to dosing;\n  * MAOIs within 30 days prior to dosing and until 14 days after the last drug administration;\n  * any drug known to induce or inhibit hepatic drug metabolism, including St. John's Wort, within 30 days prior to dosing;\n  * prescription medications within 14 days prior to dosing;\n  * any vaccine, including COVID-19 vaccine, within 14 days prior to dosing;\n  * OTC medications and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days or 5 half-lives (whichever is longer) prior to dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily).\n* History or evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis diagnosed by a positive QFT-GIT. In case of an indeterminate, borderline, or invalid result, the QFT-GIT may be repeated once or a T-SPOT® TB test may be used to confirm the result. If the results are indeterminate\u002Fborderline at repeat testing, the participant should be excluded.\n\n\\\u003CHealthy Volunteers and Patients\\>\n\n* Use of any investigational drug within 30 days or 5 half-lives of that investigational drug (whichever is longer) before the first dosing.\n* Abnormal clinical laboratory test results (and confirmed by a single repeat measurement, if deemed necessary) at Screening or admission.\n* Positive result at Screening or admission for the urine or breath alcohol screen, or urine drug screen.\n* Clinically significant abnormal laboratory test results or positive serology test results at Screening for HIV-1 Ag with HIV-1 and HIV-2 Ab, HBsAg, HBcAb (even if the result for HBcAb is positive, the negative result for HBV DNA is acceptable for study participation), or HCVAb.\n* Increased CV proarrhythmic potential, confirmed with repeat per investigator discretion, at Screening or admission.\n* Clinically significant abnormalities in blood pressure, pulse rate, oral temperature and respiratory rate at Screening or admission. If positive, the test should be repeated 2 more times and the average of the 3 results should be used to determine the participant's eligibility.\n* Poor venous access as determined by the investigator at Screening.\n* The participant smoked (including use of tobacco and\u002For nicotine containing products including e-cigarettes, snuff, chewing tobacco, cigars, pipes, or nicotine-replacement products) within 3 months before Screening or has a positive urine cotinine at Screening or admission, and the inability to stop using nicotine-containing products, during confinement in the study site. A smoker will be defined as any participant who reports nicotine containing products use or has a urine cotinine greater than 100 ng\u002FmL.\n* Female participant who is positive for pregnancy test or lactating or planning to become pregnant during this study or within 3 months after the last study intervention administration.\n* Donation of blood ≥500 mL or significant blood loss within 56 days before the first dosing, or blood plasma or platelet donation within 14 days before the first dosing, or blood transfusion within 90 days before the first dosing.\n* Participant working at or having an immediate family member (spouse or children) who works at the study site or is a staff member of the sponsor and directly involved in this trial.\n* Engagement in strenuous exercise (eg, moving large bulky items, bodybuilding) within 14 days before the first dosing.\n* Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure.\n* Any participant who, in the opinion of the investigator, is not considered to be suitable and is unlikely to comply with the study protocol for any reason.",true,"55 Years",{"count":77,"type":21},90,[79],"PHASE1","A study to investigate the safety, tolerability, and pharmacokinetics (PK) of ONO-6414 orally in healthy adult participants and in patients with active ulcerative colitis (UC).",[82],"Ulcerative Colitis (UC)",[84,85,86],"ONO-6414-01","ONO-6414","ulcerative colitis","NOT_YET_RECRUITING","2026-08-04",{"date":90,"type":32},"2026-08-06",{"date":92,"type":21},"2026-09-30",{"date":94,"type":21},"2028-01-31",{"name":38,"class":39},1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100563959","phase-2-study-to-ono-4538-in-patients-with-rhabdoid-tumor-100563959","NCT06622941","Study to ONO-4538 in Patients With Rhabdoid Tumor","A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor","Inclusion Criteria:\n\n1. Gender: Not specified\n2. Age (at the time of consent): 1 year or older\n3. Patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid Tumors\n4. Patients with advanced or recurrent rhabdoid Tumors not eligible for curative resection\n\nExclusion Criteria:\n\n1. Patients with a history of active concurrent malignancy or complications\n2. Patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period\n3. Patients with concomitant central nervous system disorders other than AT\u002FRT that are inadequately controlled or may lead to discontinuation of the investigational drug","1 Year",{"count":106,"type":21},23,[108],"PHASE2","Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors",[111],"Rhabdoid Tumor","2026-08-02",{"date":88,"type":32},{"date":115,"type":32},"2024-11-25",{"date":117,"type":21},"2030-03-31",{"name":38,"class":39},14,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100649324","phase-1-a-study-of-ono-4538hsc-in-pediatric-patients-with-malignant-solid-tumors-and-in-patients-with-epithelioid-sarcoma-100649324","NCT07734116","A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.","A Multicenter, Open-label, Uncontrolled Phase I\u002FII Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma, and to Evaluate the Tolerability in Pediatric Patients.","Inclusion Criteria:\n\n\\[Cohort of pediatric malignant solid tumor Tolerability evaluation part\\]\n\n1. Patients aged ≥ 12 to \\\u003C 18 years at the time of signing the informed consent form (ICF)\n2. Patients with radically\u002Fcuratively unresectable advanced or metastatic solid tumor who are refractory to or intolerant to standard treatment or for which no standard treatment is available.\n3. Patients with ECOG PS of 0 to 1\n\n   \\[Cohort of pediatric malignant solid tumor Expansion part\\]\n4. Patients aged ≥ 12 to \\\u003C 18 years at the time of signing the informed consent form (ICF)\n5. Patients with unresectable tumors for whom nivolumab intravenous monotherapy is indicated in adults according to the package insert\n6. Patients who have at least 1 measurable lesion per RECIST guideline\n7. Patients with ECOG PS of 0 to 2\n\n   \\[Cohort of Epithelioid Sarcoma\\]\n8. Patients aged ≥ 12 years of age at the time of signing the informed consent form (ICF). However, patients aged ≥ 12 to \\\u003C 18 years may be enrolled after tolerability is confirmed in the tolerability evaluation part in the cohort of pediatric malignant solid tumor.\n9. Patients who are refractory to or ineligible to at least 1 regimen of chemotherapy including doxorubicin for unresectable advanced or recurrent epithelioid sarcoma\n10. Patients who have at least 1 measurable lesion per RECIST guideline\n11. Patients with ECOG PS of 0 to 2\n\n    \\[Common\\]\n12. Life expectancy ≥ 3 months at the time of enrollment\n\nExclusion Criteria:\n\n1. Patients with current or previous severe hypersensitivity reactions to antibody products\n2. Patients with primary central nervous system tumor\n3. Patients with brain or meningeal metastases. However, patients who are asymptomatic and do not require treatment can be enrolled.\n4. Patients with multiple cancers\n5. Patients who have previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other therapeutic antibodies or pharmacotherapies for regulation of T cells","12 Years",{"count":129,"type":21},50,[79,108],"This is a multicenter, open-label, uncontrolled Phase I\u002FII study to evaluate the efficacy, safety, and pharmacokinetics of ONO-4538HSC in pediatric patients with malignant solid tumors and in patients with epithelioid sarcoma, and to evaluate the tolerability in pediatric patients. The objective of this study is to explore the tolerability, safety, efficacy, and pharmacokinetics of ONO-4538HSC in patients with pediatric malignant solid tumors. The other objective is to exploratively investigate the efficacy and safety of ONO-4538HSC in patients with epithelioid sarcoma.",[133],"Pediatric Malignant Solid Tumor and Epithelioid Sarcoma","2026-07-24",{"date":136,"type":32},"2026-07-29",{"date":138,"type":21},"2026-08-15",{"date":140,"type":21},"2032-02-29",{"name":38,"class":39},3,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100640091","phase-1-study-of-dcc-2618-in-patients-with-gist-after-at-least-3-prior-treatments-100640091","NCT07618377","Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments","A Phase 1 Study to Evaluate the Safety of DCC-2618 in Patients With Unresectable, Metastatic, or Recurrent Gastrointestinal Stromal Tumor (GIST) Who Are Refractory or Intolerant to at Least 3 Prior Therapies","Inclusion Criteria:\n\n1. Participants with a histologically confirmed diagnosis of GIST.\n2. Participants who are refractory or intolerant to treatment with at least imatinib, sunitinib, and regorafenib.\n3. Participants with at least one measurable lesion per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) within 28 days prior to the first administration of the investigational product.\n4. Participants with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n\nExclusion Criteria:\n\n1. Participants with a concomitant or prior history of severe hypersensitivity reactions to other tyrosine kinase inhibitors.\n2. Participants with uncontrolled diabetes mellitus.\n3. Participants with a systemic infection requiring treatment.",{"count":151,"type":21},10,[79],"To evaluate the safety of DCC-2618 in patients with unresectable, metastatic, or recurrent gastrointestinal stromal tumor (GIST) who have received three or more prior therapies",[155],"Gastrointestinal Stromal Tumors","2026-07-17",{"date":158,"type":32},"2026-07-20",{"date":160,"type":32},"2026-07-07",{"date":162,"type":21},"2028-02",{"name":38,"class":39},2,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"100588979","phase-2-a-study-to-evaluate-the-safety-and-efficacy-of-two-dose-levels-of-ono-4578-with-opdivo-in-combination-with-mfolfox6-and-bevacizumab-versus-standard-of-care-in-participants-with-non-msi-hdmmr-pd-l1-positive-advanced-colorectal-cancer-100588979","NCT06948448","A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H\u002FdMMR, PD-L1 Positive Advanced Colorectal Cancer","A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo® in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care for First-line Treatment of Non-MSI-H\u002FdMMR, PD-L1 Positive Advanced Colorectal Cancer","Inclusion Criteria:\n\n* Histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection\n* ECOG Performance Status of 0-1\n* No prior systemic treatment for advanced local or mCRC\n* Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory\n\nExclusion Criteria:\n\n* Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor\n* Participants with BRAF V600E mutation\n* Unable to swallow tablets.\n* Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis\n* Participants with an active, known or suspected autoimmune disease.\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply",{"count":173,"type":21},144,[108],"The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.",[177],"Colorectal Cancer","2026-07-15",{"date":180,"type":32},"2026-07-16",{"date":182,"type":32},"2025-11-18",{"date":184,"type":21},"2028-10-01",{"name":38,"class":39},39,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":74,"sex":17,"minAge":18,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":96},"100643658","phase-1-a-study-of-ono-3310-in-healthy-adult-male-subjects-and-chronic-kidney-disease-patients-with-type-2-diabetes-mellitus-100643658","NCT07619157","A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus","A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\nHealthy adult part\n\n1. Japanese healthy adult male subjects\n2. Age at the time of informed consent: 18 to 45\n3. BMI (at screening): 18.5 kg\u002Fm2 to less than 25.0 kg\u002Fm\\^2\n\nChronic kidney disease patient part\n\n1. Chronic kidney disease patients with type 2 diabetes mellitus\n2. Age at the time of informed consent: 18 to less than 65\n3. UACR measured by 24-hour urine collection: 300 mg\u002Fg to less than 3500 mg\u002Fg\n\nExclusion Criteria:\n\nHealthy adult part\n\n1. Subjects who currently receive treatment for or have a history of any of the following diseases: respiratory system, cardiovascular system, psychiatric system, nervous system, gastrointestinal system, immune system, liver, kidney, hematopoietic function, or endocrine function.\n2. Presence or history of severe allergy to drugs or food\n3. Presence or history of drug or alcohol dependence\n\nChronic kidney disease patient part\n\n1. Current symptoms of severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease\n2. Patients with type 1 diabetes mellitus\n3. Patients with a history of dialysis treatment","64 Years",{"count":196,"type":21},120,[79],"To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ONO-3310 in healthy Japanese adult male subjects and chronic kidney disease patients with type 2 diabetes mellitus",[200,201],"Type2 Diabetes Mellitus","Chronic Kidney Disease","2026-06-04",{"date":204,"type":32},"2026-06-08",{"date":206,"type":32},"2026-06-02",{"date":208,"type":21},"2027-11-30",{"name":38,"class":39},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":219,"phases":4,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},"100605989","a-retrospective-observational-study-of-nivolumab-in-combination-with-chemotherapy-as-neoadjuvant-therapy-for-resectable-nsclc-patients-real-world-experience-in-taiwan-neoreal-100605989","NCT07169708","A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)","A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan","Inclusion Criteria:\n\n1. Aged 18 years and older\n2. Patients who are diagnosed with pathologically confirmed, non-metastatic, resectable NSCLC\n3. Patients who have received at least one cycle of neoadjuvant nivolumab combined with chemotherapy since the approval of the regimen in February 2023, and who have at least one imaging assessment of EFS and surgical status recorded. For patients who underwent surgery, at least one pathological report is required.\n4. Patients who have been followed up for at least 12 months (from first dose of neoadjuvant therapy to last medical record date at study site), exceptional case as follows:\n\n   * Patients who expired within 12 months of follow-up\n   * Patients who experience disease progression or recurrence but continue to follow-up\n5. Participants with histologically confirmed Stage II-III NSCLC (per the 8th International Association for the Study of Lung Cancer) who are considered resectable.\n\nExclusion Criteria:\n\n1. Patients with distant metastasis (M1 disease according to the eighth edition of the American Joint Committee on Cancer \\[AJCC\\] cancer staging manual) prior to neoadjuvant therapy\n2. Patients with N3 disease per AJCC 8th edition\n3. Patients with known EGFR mutations or ALK translocation\n4. Patients who have received any prior systemic therapy for NSCLC\n5. Patients with a history of previous cancers or other concurrent malignancies within 10 years before the first dose of nivolumab",{"count":218,"type":21},100,"OBSERVATIONAL","The goal of this observational study is to learn about the effectiveness of Nivolumab in combination with chemotherapy as Neoadjuvant therapy for patients with non-small cell lung cancer (NSCLC). The main question it aims to answer is:\n\nDoes patient with NSCLC in treatment of Nivolumab combined with chemotherapy demonstrate better pCR and PFS ? Is it safe for patient with NSCLC in treatment of Nivolumab combined with chemotherapy ?\n\nThe data for those participants already receiving nivolumab in combination with chemotherapy as part of their regular medical care for NSCLC will be collected within the designated collection period.",[222],"Non Small Cell Lung Cancer NSCLC",[224,225,226,227,228],"NeoReal","NSCLC","Nivolumab","Opdivo","Neoadjuvant therapy","2026-05-18",{"date":231,"type":32},"2026-05-20",{"date":233,"type":32},"2026-03-20",{"date":235,"type":21},"2026-06-30",{"name":38,"class":39},9,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":245,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":96},"100639370","phase-3-a-study-to-evaluate-the-safety-efficacy-and-pk-of-ono-2017-in-japanese-patients-with-pos-2-to-17-year-olds-100639370","NCT07594158","A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds","A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years.","Inclusion Criteria:\n\n* Japanese male or female patients aged 2 to under 18 years at the time of informed consent.\n* Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized seizures.\n* Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective patient epilepsy diary, etc.\n* Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.\n\nExclusion Criteria:\n\n* Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.\n* Patients with a history of non-epileptic psychogenic seizures.\n* Patients with simple partial seizures without motor symptoms or idiopathic generalized epilepsy.\n* Patients diagnosed with Lennox-Gastaut syndrome.\n* Patients with a history of serious drug-induced hypersensitivity reaction (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, drug-induced hypersensitivity syndrome \\[DIHS\\]) or drug-induced rash requiring hospitalization.","2 Years","17 Years",{"count":248,"type":21},20,[24],"Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures",[252],"Partial Epilepsy","2026-05-11",{"date":229,"type":32},{"date":256,"type":21},"2026-05-30",{"date":258,"type":21},"2029-12-31",{"name":38,"class":39},{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},"100577863","phase-2-a-study-of-ono-2020-in-patients-with-agitation-associated-with-alzheimers-disease-dementia-100577863","NCT06803823","A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia","A Phase 2a, Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia","Inclusion Criteria:\n\n* Diagnosis of probable AD according to the diagnostic criteria for AD dementia (NIA-AA 2011)\n* Mini-Mental State Examination (MMSE) score ≥ 5 to ≤ 22 at the start of the treatment period\n* Symptoms of agitation defined by the IPA from at least 14 days before the start of the screening period\n* Neuropsychiatric Inventory-Nursing Home version (NPI-NH) Agitation\u002FAggression domain (NPI-NH-A\u002FA) score ≥ 4 at the start of the treatment period.\n* Patients who can participate in the study under hospitalization from 21 days before the start of the treatment period to throughout the treatment period\n\nExclusion Criteria:\n\n* Diagnosis of dementia not due to AD or any other disorder with memory impairment, such as mixed dementia, vascular dementia, Lewy body dementia, dementia associated with Parkinson's disease, frontotemporal dementia, drug-induced dementia, dementia associated with human immunodeficiency virus (HIV) infection, traumatic brain injury, normal pressure hydrocephalus, or other non-AD dementia\n* Any MRI or CT scan of the brain performed after the onset of dementia with findings consistent with clinically relevant CNS disease other than AD, such as vascular changes (eg, cortical cerebral infarction, multiple cerebral infarctions), space-occupying lesions (eg, tumors), or any other major structural brain disease\n* Delirium within 30 days before the start of the screening period or a history of delirium\n* At risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) (answers \"yes\" to Question 4 or 5 of the suicidal ideation section of the C-SSRS) or any suicide attempt within 6 months before the start of the screening period, or at serious risk of suicide in the opinion of the investigator or subinvestigator\n* Prior or current treatment with anti-amyloid beta antibodies","90 Years",{"count":77,"type":21},[108],"To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.",[272],"Agitation Associated With Alzheimer's Disease Dementia","2026-05-10",{"date":275,"type":32},"2026-05-12",{"date":277,"type":32},"2025-05-01",{"date":279,"type":21},"2027-03-31",{"name":38,"class":39},38,{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":151},"100588096","phase-2-ono-4538-study-in-patients-with-richters-transformation-100588096","NCT06936943","ONO-4538 Study in Patients With Richter's Transformation","A Multicenter, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of ONO-4538 in Patients With Richter's Transformation","Inclusion Criteria:\n\n* Histological diagnosis of diffuse large B-cell lymphoma (DLBCL)-type or Hodgkin lymphoma(HL)-type Richter's transformation with a history of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)\n* In the case of DLBCL-type Richter's transformation, refractory, intolerant or ineligible for treatment of DLBCL\n* Patients with measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Expected to survive for 90 days or more\n\nExclusion Criteria:\n\n* Serious complications\n* Active multiple cancers\n* Active central nervous system (CNS) disease\n* History of allogeneic hematopoietic stem cell transplantation",{"count":119,"type":21},[108],"Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation",[293],"Richter's Transformation","2026-02-12",{"date":296,"type":32},"2026-02-13",{"date":298,"type":32},"2025-11-19",{"date":300,"type":21},"2030-07-31",{"name":38,"class":39},{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":248},"100445349","phase-1-study-of-ono-4685-in-patients-with-relapsed-or-refractory-t-cell-lymphoma-100445349","NCT05079282","Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma","An Open-label, Multi-center, Non-randomized Phase I Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma","Inclusion Criteria\n\n1. Patients aged ≥ 18 years at time of screening\n2. Written informed consent by the patient or the patients' legally authorized representative prior to screening\n3. Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:\n\n   1. Peripheral T-cell lymphoma (PTCL): Angioimmunoblastic T-cell lymphoma (AITL), PTCL, not otherwise specified (PTCL-NOS), nodal PTCL with T-follicular helper (TFH) and follicular T-cell lymphoma (FTCL)\n   2. Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)\n4. Patients must have received at least 2 prior systemic therapies\n5. Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014)\n6. Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011)\n7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2\n8. Life expectancy of at least 3 months\n9. Adequate bone marrow, renal and hepatic functions\n\nExclusion Criteria:\n\n1. Patients with central nervous system (CNS) involvement\n2. Patients with Adult T-cell leukemia\u002Flymphoma (ATLL)\n3. Prior allogeneic stem cell transplant\n4. Prior treatment with ONO-4685, anti-PD-1, anti-PD-L1, anticytotoxic T lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n5. Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy\n6. Patients with malignancies (other than T-cell lymphoma) except for completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, or any other malignancies that has not relapsed for at least 2 years\n7. History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)\n8. History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment\n9. Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection\n10. Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies\n11. Women who are pregnant or lactating",{"count":310,"type":21},217,[79],"This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma",[314],"Relapsed or Refractory T Cell Lymphoma",[316,317,318,319,320,321,322,323,324,325,326,327],"ONO-4685","PD-1","CD3","Bispecific antibody","PTCL","AITL","PTCL-NOS","nodal PTCL with TFH","FTCL","CTCL","MF","SS","2026-02-11",{"date":296,"type":32},{"date":331,"type":32},"2021-12-10",{"date":333,"type":21},"2028-08-31",{"name":38,"class":39},{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":356},"100560624","phase-3-ono-2017-study-japanese-patients-with-primary-generalized-tonic-clonic-seizures-100560624","NCT06579573","ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.","ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.","Inclusion Criteria:\n\n1. Gender and age: Japanese patients, regardless of gender, aged 12 years or older at the time of informed consent.\n2. Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy.\n3. Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.\n4. Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens\n\nExclusion Criteria:\n\n1. Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.\n2. Subject has seizure clusters where individual seizures cannot be counted orclassified.\n3. History of non-epileptic or psychogenic seizures.\n4. Subject has a concomitant diagnosis of Partial Onset Seizure(POS).\n5. Subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms(DRESS), Drug-induced hypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.",{"count":343,"type":21},15,[24],"To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.",[347],"Epilepsy, Generalized","2025-06-15",{"date":350,"type":32},"2025-06-17",{"date":352,"type":32},"2022-07-12",{"date":354,"type":21},"2027-01-31",{"name":38,"class":39},25,{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":375,"locationsCount":376},"100561494","phase-2-safety-of-cenobamate-in-japanese-subjects-with-partial-onset-seizures-100561494","NCT06590896","Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures","A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures","Inclusion Criteria:\n\n* Subjects completed Study YKP3089C035 by SK Life Science.\n\nExclusion Criteria:\n\n* Subjects that have previously discontinued for any reason from the Core study (YKP3089C035).\n* Any significant changes to the medical history of the subject that in the opinion of the investigator, could affect the safety of the subject.",{"count":218,"type":21},[108],"To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures",[368],"Epilepsies, Partial","2025-06-01",{"date":371,"type":32},"2025-06-03",{"date":373,"type":32},"2022-11-04",{"date":354,"type":21},{"name":38,"class":39},29,{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":381,"conditions":387,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":119},"100558162","phase-1-a-phase-i-study-to-investigate-the-tolerability-and-safety-of-ono-4685-given-as-monotherapy-in-t-cell-lymphoma-and-cllsll-100558162","NCT06547528","A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL\u002FSLL","An Open-label, Uncontrolled, Phase I Dose Escalation Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)","Inclusion Criteria:\n\n1. Patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:\n\n   Peripheral T-cell lymphoma(PTCL)\n   * Angioimmunoblastic T-cell lymphoma(AITL)\n   * Peripheral T-cell lymphoma, NOS(PTCL-NOS)\n   * Nodal peripheral T-cell lymphoma with TFH phenotype(nodal PTCL with TFH)\n   * Follicular T-cell lymphoma(FTCL) Cutaneous T-cell lymphoma(CTCL)\n   * Mycosis fungoides(MF)\n   * Sezary syndrome Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma(CLL\u002FSLL)\n2. Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator\n3. ECOG PS 0\\~2\n4. Life expectancy of at least 3 months\n\nExclusion Criteria:\n\n1. Patients with severe complications.\n2. Patients with multiple cancers.",{"count":385,"type":21},108,[79],[388],"Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma",{"date":371,"type":32},{"date":391,"type":32},"2023-10-01",{"date":393,"type":21},"2029-04-30",{"name":38,"class":39},{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":17,"minAge":402,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":281},"100405975","phase-2-ono-4538-phase-ii-rollover-study-ono-4538-98-100405975","NCT04566380","ONO-4538 Phase II Rollover Study (ONO-4538-98)","A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination With Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98)","Inclusion Criteria:\n\n1. Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials\n2. Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and\u002For investigator-assessed clinical benefit\n\nExclusion Criteria:\n\n1. Participant judged to be incapable of providing consent for reasons such as concurrent dementia\n2. Participant judged by the investigator to be inappropriate as participants of this study","16 Years",{"count":404,"type":21},59,[108],"This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.",[408],"Pan-tumor",{"date":371,"type":32},{"date":411,"type":32},"2020-09-10",{"date":413,"type":21},"2026-12-31",{"name":38,"class":39},""]