[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma-adult":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,86,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100302121","phase-1-oral-capecitabine-and-temozolomide-captem-for-newly-diagnosed-gbm-100302121",false,"NCT03213002","Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM","Phase I\u002FII Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)","CAPTEM","Inclusion Criteria:\n\n1. Be capable of giving informed consent.\n2. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV\n3. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide\n4. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential\n5. Have a life expectancy \\> 3 months\n6. Be between the ages of 18 to 74\n7. Have a performance status KPS 70 or greater\n8. Be able to swallow pills and capsules\n9. Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings\n10. Have adequate bone marrow function, liver function and renal function before commencing therapy\n\nExclusion Criteria:\n\n1. Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded.\n2. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.\n3. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),\n4. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)\n5. Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past one year).\n6. Performance status, KPS \\\u003C 70\n7. Inability to swallow pills and capsules\n8. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy\n9. Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine\n10. Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance\n11. Patients with renal insufficiency or hepatic insufficiency\n12. Patients with coagulopathies\n13. Women who are pregnant or lactating.","ALL","18 Years","74 Years",{"count":21,"type":22},67,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM).\n\nCapecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg\u002Fm2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.",[29,30,31,32,33,34,35,36,37],"Glioblastoma Multiforme (GBM)","Glioblastoma","Glioma of Brain","Glioblastoma, Adult","Brain Tumor","Brain Tumor, Primary","Brain Tumor Adult","Cancer","Brain Cancer","RECRUITING","2026-05-28",{"date":41,"type":42},"2026-06-01","ACTUAL",{"date":44,"type":42},"2017-06-13",{"date":46,"type":22},"2029-06",{"name":48,"class":49},"Northwell Health","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100589455","prognostic-potential-of-olfactory-function-in-glioblastoma-a-prospective-observational-study-100589455","NCT06954636","Prognostic Potential of Olfactory Function in Glioblastoma: a Prospective Observational Study","OLFGBM","Inclusion Criteria:\n\n* At least 18 years of age\n* Newly-diagnosed glioblastoma (IDH wild-type)\n* Never received prior chemotherapy\n* Never received radiotherapy to the head or neck before\n* KPS ≥ 70\n* No history of severe head or brain trauma requiring ICU admission or classified as Glasgow Coma Scale grade 3\n* No respiratory infection at the time of inclusion\n* No significant aphasia\n\nExclusion Criteria:\n\n* Presence of Neurodegenerative diseases (e.g. Parkinson's disease, Alzheimer's disease, Huntington's disease, Korsakoff's syndrome, Pick's disease, Shy-Drager syndrome)\n* History of invasive tumors or surgery in the head or neck area, except for surgeries for non-invasive skin tumors (e.g. basal cell carcinomas)\n* Permanent olfactory impairment following infections (e.g., influenza, coronavirus)\n* Conditions that, in the examiner's judgment, could interfere with the participant's study compliance (e.g., schizophrenia)\n* Language barriers likely to interfere with participation or comprehension of study procedures.",true,{"count":60,"type":22},128,"OBSERVATIONAL","The study aims to investigate the prognostic significance of olfactory function in patients with glioblastoma. We are examining olfactory function at various points during therapy and correlating the results with survival data. In addition, neurocognitive tests will be carried out to correlate the results of olfactory function with the patient's cognitive abilities. Investigations into the quality of life and psychological condition of the patients are also performed. In addition to the cohort of glioblastoma patients, there is a control cohort without tumor disease in which the olfactory testing is also carried out in order to have a comparison.",[64,65,32],"Glioblastoma Multiforme, Adult","Glioblastoma or Gliosarcoma",[67,68,69,70,71,72,73,74,75],"olfactory dysfunction","threshold test","identification test","glioblastoma","prognosis","observational study","olfactory function","neurocognition","quality of life","2025-07-02",{"date":78,"type":42},"2025-07-08",{"date":80,"type":42},"2023-05-03",{"date":82,"type":22},"2028-12-31",{"name":84,"class":49},"Sied Kebir",2,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":85},"100585437","phase-1-safety-pharmacokinetics-and-preliminary-efficacy-of-cs231295-in-advanced-solid-tumors-100585437","NCT06902350","Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CS231295 in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Understand and sign the informed consent form voluntarily.\n2. ≥18 years old when signing the informed consent, regardless of sex.\n3. Have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors (including but not limited to small cell lung cancer, glioblastoma, urothelial carcinoma, endometrial cancer, cervical cancer, ovarian cancer, breast cancer, and liver cancer) for which standard therapy has failed or was intolerable, and currently no standard treatment is available.\n\n   * Radiological or histopathological evidence indicating disease progression should be documented.\n   * Intolerance is defined as discontinuation of treatment due to adverse events during therapy.\n   * Recurrence is based on radiological or histopathological results.\n4. For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. Note: Target lesions can be located in previously irradiated areas, but must be confirmed by imaging to show disease progression after radiation.\n5. For glioblastoma: KPS score ≥60. For other solid tumors: ECOG performance status of 0 or 1.\n6. Meet the following laboratory criteria (without receiving any blood products, hematopoietic growth factors, albumin, or other treatments within 14 days prior to testing, except iron supplements):\n\n   * Hematology: Hemoglobin (Hb) ≥100 g\u002FL, absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet (PLT) count ≥100×10\\^9\u002FL.\n   * Biochemistry: 1) Dose escalation phase: Serum creatinine (Cr) ≤ upper limit of normal (ULN); total bilirubin (TBIL) ≤1.25×ULN; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤1.5×ULN (for subjects with liver metastases or hepatocellular carcinoma: ≤3×ULN). 2) Cohort expansion phase: Cr ≤1.5×ULN; TBIL ≤1.5×ULN; ALT, AST ≤2.5×ULN (for subjects with liver metastases or hepatocellular carcinoma: ≤5×ULN).\n   * Coagulation: International normalized ratio (INR) ≤1.5×ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN (for participants receiving prophylactic anticoagulation, the INR and APTT should be within a safe and effective therapeutic range as judged by the investigator).\n   * Urinalysis: Urine protein \\\u003C2+; if ≥2+, a 24-hour urine protein quantification should be performed. \\\u003C1 g\u002F24 h can be enrolled but ≥1 g\u002F24 h is prohibited. without quantification when urine protein ≥2+ is not allowed.\n7. Expected survival ≥12 weeks.\n8. Cohort Expansion Phase: 1) Cohort 1: Histologically or cytologically confirmed small cell lung cancer (SCLC) that has progressed or recurred after at least two lines of systemic chemotherapy (including a platinum-based regimen). Note: A new line of treatment is defined as a change in treatment due to disease progression, not due to toxicity or other reasons. Re-initiation of the same treatment regimen after initial progression is considered a new line of treatment. 2) Cohort 2: Recurrent or progressive glioblastoma confirmed by histopathology or imaging, which has progressed or recurred after at least one prior treatment with temozolomide.\n\nExclusion Criteria:\n\n1. Received any form of intracranial radiotherapy within 3 months prior to the first dose.\n2. Received any anti-tumor treatment (including but not limited to chemotherapy, targeted therapy, immunotherapy, cellular therapy, radiation therapy \\[see exclusion criterion #1 for head\\], endocrine anti-tumor therapy, tumor embolization) or unapproved investigational drugs or devices within 28 days prior to the first dose. Also, received Traditional Chinese Medicine (TCM) approved by the National Medical Products Administration (NMPA) for treating malignant tumors within 14 days prior to the first dose.\n3. Previously received Aurora kinase inhibitors.\n4. Used strong inducers or inhibitors of cytochrome P450 3A (CYP3A) enzymes within 14 days prior to the first dose or are still within 7 half-lives of such drugs (whichever is longer).\n5. For glioblastoma only: \\>5 mg\u002Fday dexamethasone or equivalent doses of other glucocorticoids for systemic treatment related to glioblastoma within 1 week prior to the first dose.\n6. Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures as judged by the investigator at screening.\n7. Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1, except for alopecia or laboratory abnormalities deemed no clinical significant by the investigator.\n8. History of other primary malignancies within 5 years prior to the first dose, except for adequately treated in situ carcinoma, non-melanoma skin cancer, or malignant melanosis.\n9. For solid tumors other than glioblastoma: Unstable brain metastases. Stable brain metastases are allowed if:\n\n   * No immediate or planned local treatment for brain metastases during the study.\n   * No neurological symptoms or signs (e.g., increased intracranial pressure, seizures, cognitive impairment) at screening.\n   * Brain lesions stable for ≥2 weeks prior to the first dose without corticosteroid or anticonvulsant treatment.\n10. Leptomeningeal metastasis (except glioblastoma).\n11. Severe brain herniation or risk thereof.\n12. For glioblastoma only: who had wafer(s) implantation during surgery.\n13. Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms (e.g., chest tightness, shortness of breath, dyspnea).\n14. Uncontrolled or significant cardiovascular disease, including:\n\n    * NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose, or arrhythmias requiring treatment, left ventricular ejection fraction (LVEF) \\\u003C50% at screening.\n    * Primary cardiomyopathy (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive, or unclassified cardiomyopathy).\n    * Symptomatic coronary artery disease requiring medication at screening.\n    * Clinically significant QTcF prolongation history or QTcF \\>470 ms (females) and \\>450 ms (males) at screening.\n    * Significant cerebrovascular accident (including cerebral hemorrhage, transient ischemic attack) within 6 months prior to the first dose.\n    * Use of ≥3 antihypertensive drug components within 14 days prior to the first dose or inadequately controlled blood pressure (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) at screening.\n    * Other cardiovascular conditions deemed unsuitable by the investigator.\n15. Poorly controlled diabetes (fasting glucose \\>10 mmol\u002FL).\n16. Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, bowel obstruction, small bowel resection, or total gastrectomy).\n17. Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose (e.g., gastrointestinal bleeding); currently on anticoagulants (e.g., warfarin, phenprocoumon, but low-dose aspirin and heparin for prophylaxis allowed); high-risk bleeding tendency at screening (e.g., esophageal varices, active ulcerative lesions, positive occult blood in stool, imaging evidence of tumor invasion into large vessels).\n18. Serious thromboembolic events within 6 months prior to the first dose (e.g., arterial thrombosis, pulmonary embolism, deep vein thrombosis). Implanted venous port or catheter-related thrombi, superficial vein thrombi, or those deemed stable and not requiring emergency medical intervention are not considered \"serious.\"\n19. Active infection requiring intravenous treatment at screening. Severe infections (e.g., hospitalization due to infection, bacteremia, severe pneumonia complications) within 28 days prior to the first dose. Patients receiving prophylactic antibiotics (e.g., for urinary tract infections or COPD exacerbations) can be enrolled.\n20. Known active tuberculosis, currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to the first dose.\n21. Active hepatitis B (HBsAg or HBcAb positive with viral replication) or hepatitis C (HCV antibody positive with viral replication) at screening.\n22. Human immunodeficiency virus (HIV) infection or syphilis infection (positive specific antibody test followed by positive non-specific antibody test) at screening.\n23. Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.\n24. History of organ transplantation or allogeneic hematopoietic stem cell transplantation.\n25. History of alcohol abuse or drug abuse.\n26. Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.\n27. Unwilling or unable to use effective contraception methods during the entire treatment period and up to 3 months after the last dose for women of childbearing potential (defined as having experienced menarche and not undergone successful artificial sterilization \\[hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\\] or not postmenopausal) or male patients whose partners are women of childbearing potential; pregnant or breastfeeding women.\n28. Other conditions deemed unsuitable for participation in this trial by the investigator.",{"count":94,"type":22},102,[25],"This trial is a single-arm, open-label, first-in-human study of CS231295, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The Dose-Limiting Toxicity (DLT) observation period includes 6 days for single-dose and the first cycle (28 days) for multiple-dose. The overall study consists of screening period, treatment period, and follow-up period.\n\nThe primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS231295 in patients with advanced solid tumors, and to recommended Phase 2 dose(s) (RP2D) of CS231295 in appropriate tumor(s).",[98,32,99],"Neoplasms","Small Cell Lung Carcinoma (SCLC)","2025-05-22",{"date":102,"type":42},"2025-05-25",{"date":104,"type":42},"2025-05-21",{"date":106,"type":22},"2029-04",{"name":108,"class":109},"Chipscreen Biosciences, Ltd.","INDUSTRY",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":119,"studyType":61,"phases":4,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100581031","csf-proteomic-characterization-of-glioblastomas-100581031","NCT06845020","CSF Proteomic Characterization of Glioblastomas","The Effects of CSF of Patients with Glioblastomas on the Microglial Immune Profile","Inclusion Criteria:\n\n* Patients with confirmed diagnosis of glioblastoma (histopathological and molecular).\n* Patients who voluntarily accept participation in this study.\n* Patients aged 18 or older.\n\nExclusion Criteria:\n\n* Patients who cannot be followed up at the Regional Hospital 'Dr. Valentin Gomez Farias' ISSSTE.\n* Contamination of the required sample (CSF, serum, tumor).\n* Patients with whom no sampling was obtained or subjects with incomplete background information.\n* Patients who decide to withdraw participation from the study.",{"count":118,"type":22},15,"12 Months","The goal of this observational study is to identify proteins that can be found in the cerebrospinal fluid (CSF) of patients with grade IV brain tumors, specifically glioblastomas, and correlate these proteins with progression free survival, overall survival and performance status (functionality). All participants with high probability of glioblastoma will initially be included, final inclusion will be dependent on the definitive histopathological diagnosis of the tumor.\n\nThe main question is:\n\nCan the researchers identify a proteomic profile in CSF from study participants with glioblastoma in association with a longer progression free survival? Participants will undergo the following procedures, that do not deviate from normal standard diagnostic care.\n\n1. Lumbar puncture to obtain CSF.\n2. Blood draw.\n3. Trans-surgical tissue sample of the brain tumor. Additionally participants will be planned for follow up appointments every 3 months following the first 12 months after the surgical tumor resection.",[30,122,123,124,32],"Glioblastoma WHO Grade IV","Glioblastoma (GBM)","Glioblastoma Multiforme of the Brain",[30,126,127,128,129,130],"Cerebrospinal fluid","CSF","GBM","Proteomics","Biomarker","NOT_YET_RECRUITING","2025-02-21",{"date":134,"type":42},"2025-02-25",{"date":136,"type":22},"2025-03-01",{"date":138,"type":22},"2028-03-30",{"name":140,"class":49},"Univeridad Autonoma de Guadalajara"]