[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cushing-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cushing-disease":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,47,73,99,128,160,179,204,228],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":4,"leadSponsor":43,"locationsCount":46},"100054596","an-investigation-of-pituitary-tumors-and-related-hypothalmic-disorders-100054596",false,"NCT00001595","An Investigation of Pituitary Tumors and Related Hypothalmic Disorders","A Clinical and Genetic Investigation of Pituitary and Hypothalamic Tumors and Related Disorders","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Male or female with:\n\n   1. Evidence for the existence of a tumor of the hypothalamic-pituitary unit or related disorder, as indicated by previously obtained imaging studies or biochemical investigation of the hypothalamo-hypophyseal function (aged 2 years to 70 years)\n\n      or\n   2. Family members (any age) of patients with a family history of tumors of the hypothalamic-pituitary unit or related disorders as part of the linkage part of the study, or\n   3. Members (any age) of a kindred suspected of having an inherited form of neoplasia of the hypothalamic-pituitary unit or related disorder, as evidenced by results of a patient enrolled in this protocol, as part of the linkage part of the study\n3. Ability of the subject or LAR to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy: Pregnancy will be evaluated only in participants of reproductive age (from 10 years old until 60 years of age unless menopause has already occurred per clinical report of the participant).\n\n   For participants enrolled as external participants or under the Linkage study (where research activities include no more than blood draws), any female who could possibly become pregnant will be screened using clinical criteria (history, with pregnancy testing only if indicated) for exclusion and this information will be documented in the consent process note in EMR. If a participant has initially been registered as external location and then presents on-site, then pregnancy test will be performed if within the reproductive age group.\n2. Patients with any medical, physical, psychiatric, or social condition, which, in the opinion of the investigators, would make participation in this protocol not in their best interest, will be excluded from the study.\n3. Patients who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on CC or NICHD resources may be excluded.",true,"ALL","2 Years","70 Years",{"count":21,"type":22},2000,"ESTIMATED","OBSERVATIONAL","There is a variety of tumors affecting the pituitary gland in childhood; some of these tumors (eg craniopharyngioma) are included among the most common central nervous system tumors in childhood. The gene(s) involved in the pathogenesis of these tumors are largely not known; their possible association with other developmental defects or inheritance pattern(s) has not been investigated. The present study serves as a (i) screening\u002Ftraining, and, (ii) a research protocol.\n\nAs a screening and training study, this protocol allows our Institute to admit children with tumors of the hypothalamic-pituitary unit to the pediatric endocrine clinics and wards of the NIH Clinical Center for the purposes of\n\n(i) training our fellows and students in the identification of genetic defects associated with pituitary tumor formation, and\n\n(ii) teaching our fellows and students the recognition, management and complications of pituitary tumors\n\nAs a research study, this protocol aims at\n\n(i) developing new clinical studies for the recognition and therapy of pituitary tumors; as an example, two new studies have emerged within the context of this protocol: (a) investigation of a new research magnetic resonance imaging (MRI) tool and its usefulness in the identification of pituitary tumors, and (b) investigation of the psychological effects of cortisol secretion in pediatric patients with Cushing disease. Continuation of this protocol will eventually lead to new, separate protocols that will address all aspects of diagnosis of pituitary tumors and their therapy in childhood.\n\n(ii) Identifying the genetic components of pituitary oncogenesis; those will be investigated by (a) studying the inheritance pattern of pituitary tumors in childhood and their possible association with other conditions in the families of the patients, and (ii) collecting tumor tissues and examining their molecular genetics. As with the clinical studies, the present protocol may help generate ideas for future studies on the treatment and clinical follow up of pediatric patients with tumors of the pituitary gland and, thus, lead to the development of better therapeutic regimens for these neoplasms.",[26,27,28,29],"Panhypopituitarism","Gigantism\u002FAcromegaly","Prolactinoma","Cushing Disease",[31,32,33,34,29,35],"Developmental Defect","Oncogenesis","Evaluation and Management","Psychological","Natural History","RECRUITING","2026-06-23",{"date":39,"type":40},"2026-06-24","ACTUAL",{"date":42,"type":40},"1997-04-21",{"name":44,"class":45},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"100628330","early-phase-1-fet-petct-imaging-to-localize-pituitary-adenomas-in-cushing-disease-100628330","NCT07460232","FET PET\u002FCT Imaging To Localize Pituitary Adenomas In Cushing Disease","18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease","Inclusion Criteria:\n\nPatients must meet ALL criteria listed below for entry:\n\n* Biochemically diagnosed ACTH-dependent Cushing disease.\n* No previous pituitary surgery.\n* Planned to undergo pituitary surgery for localization\u002Fresection of adenoma.\n* No contraindications for PET\u002FCT.\n* Recent (within 3 months) pituitary MR, or pending pituitary MR to be performed as close as possible to FET PET\u002FCT.\n* Age ≥ 18 years.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential\n* Declining to use effective contraceptive methods during the study (for individuals of child-bearing potential)\n* Need for emergent surgery that would be delayed by participation\n* Bacterial, viral, or fungal infections requiring systemic therapy\n* Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator could compromise patient safety and\u002For protocol objectives\n* Known diagnosis of autoimmune disorders\n* Patients receiving any other investigational agent within the past 28 days\n* Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the FET injection.\n* Known hypersensitivity to any excipients used in FET","18 Years",{"count":56,"type":22},50,"INTERVENTIONAL",[59],"EARLY_PHASE1","The purpose of this research is to evaluate the performance \\[sensitivity, specificity, accuracy\\] of FET PET\u002FCT imaging to detect ACTH-secreting pituitary adenoma, using operative findings and histopathology as truth standard.",[29,62],"Pituitary Adenoma","2026-06-17",{"date":65,"type":40},"2026-06-22",{"date":67,"type":40},"2026-04-27",{"date":69,"type":22},"2028-07",{"name":71,"class":72},"Mayo Clinic","OTHER",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":46},"100349603","long-term-follow-up-of-survivors-of-pediatric-cushing-disease-100349603","NCT03831958","Long-Term Follow-Up of Survivors of Pediatric Cushing Disease","Long-Term Follow-UP of Survivors of Pediatric Cushing Disease","* INCLUSION CRITERIA:\n\n  1. Males and females 10-42 years old (subjects) who were previously diagnosed and had successful treatment of CD before the age of 21 years old. Patients who have undergone therapies other than surgical resection (such as radiation or medical treatment) will be eligible to participate.\n  2. Normocortisolemia or hypocortisolemia at the time of the study (as documented within past 6 months of recruitment) documented as urine free cortisol or midnight\u002Fafternoon serum or salivary cortisol levels within or below the normal range or documented panhypopituitarism (on glucocorticoid replacement).\n  3. Patients or a legal guardian (in case of cognitively impaired adults or children) must provide assent\u002Fconsent at the time of the recruitment.\n  4. Family members (2- 90 yrs.) of patients with a family history of pituitary tumors and who agree to participate in the DNA\u002Flinkage analysis study.\n\nEXCLUSION CRITERIA:\n\n1. Pregnancy\n2. Patients with any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in their best interest, will be excluded from the on-site visit of the study. Patients who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on Clinical Center or NICHD resources will be excluded. They will still be offered the opportunity to participate in the online questionnaire part of the study.","90 Years",{"count":82,"type":22},600,"Background:\n\nThe pituitary gland produces hormones. A tumor in this gland can cause it to produce too much of the hormone cortisol. Too much cortisol in the body causes Cushing disease. This disease causes many problems. Some of these problems might persist after the disease is cured.\n\nObjective:\n\nTo find out the long-term effects of exposure to high levels of cortisol during childhood and adolescence.\n\nEligibility:\n\nPeople ages 10-42years who were diagnosed with Cushing disease before age 21 and are now cured and have normal or low cortisol levels\n\nPeople related to someone with Cushing disease\n\nDesign:\n\nParticipants will be screened with a medical history.\n\nParticipants will complete an online survey. This will include questions about their or their child s physical and mental health.\n\nAll participants will be seen at 5 -year intervals after cure of Cushing disease (5yr, 10yr, 15yr, 20yr (last visit))\n\nParticipants who have a relative with Cushing disease will have a medical history and blood tests or cheek swabs.\n\nParticipants who have the disease will have:\n\nPhysical exam\n\nBlood tests\n\nCheek swab\n\nDXA scan: A machine will x-ray the participant s body to measure bone mineral content.\n\nFor participants who are still growing, a hand x-ray\n\nParticipants with the disease may also have:\n\nHormone stimulation test: Participants will get a hormone or another substance that will be measured.\n\nSerial hormone sampling: Participants blood will be measured several times through a thin plastic tube in an arm vein.\n\nUrine tests: Participants urine may be collected over 24 hours.\n\nMRI: Participants may have a dye injected into a vein. They will lie on a table that slides into a machine. The machine will take pictures of the body.",[29],[86,87,88,89,90,35],"Body Mass Index Z Score","Adult Height","Endocrine Function","Neuropsychological Outcome","Metabolic Syndrome","2026-06-13",{"date":93,"type":40},"2026-06-16",{"date":95,"type":40},"2019-03-04",{"date":97,"type":22},"2040-01-03",{"name":44,"class":45},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":57,"phases":108,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":46},"100501085","phase-1-a-study-to-evaluate-the-safety-and-pk-of-crn04894-for-the-treatment-of-cushings-syndrome-100501085","NCT05804669","A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome","A Phase 1b\u002F2a Open-label Multiple-ascending Dose Exploratory Study of CRN04894 in ACTH-dependent Cushing's Syndrome (Cushing's Disease or Ectopic ACTH Syndrome)","Inclusion Criteria:\n\n1. Adult male or female, aged 18 years or more\n2. Evidence of chronic 'active' ACTH-dependent Cushing's syndrome\n3. Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1\n4. Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to Investigator's judgment. Participants with documented ACTH-dependent Cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating\n2. History of bilateral adrenalectomy\n3. Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm\n4. Presence of any known malignancy\n5. Use of mitotane\n6. Previous unsuccessful surgery for Cushing's syndrome within 6 weeks",{"count":107,"type":22},18,[109,110],"PHASE1","PHASE2","A Phase 1b\u002F2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone \\[ACTH\\] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \\[EAS\\])",[113,29,114],"Cushing Syndrome","Ectopic ACTH Syndrome",[113,29,114,116,117],"CRN04894","atumelnant","2026-06-02",{"date":120,"type":40},"2026-06-04",{"date":122,"type":40},"2023-10-12",{"date":124,"type":22},"2026-10",{"name":126,"class":127},"Crinetics Pharmaceuticals Inc.","INDUSTRY",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":46},"100628591","evaluation-of-positron-emission-tomography-pet-with-18ffet-for-the-detection-of-acth-secreting-corticotroph-pituitary-neuroendocrine-tumors-100628591","NCT07463625","Evaluation of Positron Emission Tomography (PET) With [18F]FET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors.","Evaluation of [18F]FET PET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors","PiTFET","Inclusion Criteria:\n\n* Adults (≥18 years).\n* Biochemical diagnosis of Cushing's disease as part of initial management.\n* Pituitary MRI performed; if visible, microadenoma \\\u003C10 mm in diameter.\n* Indication for discussion in multidisciplinary tumor board for surgical management.\n\nExclusion Criteria:\n\n* Minor (age \\\u003C18 years).\n* Macroadenoma of the pituitary.\n* ACTH-dependent hypercortisolism secondary to ectopic secretion.",{"count":137,"type":22},20,"Cushing's disease results from adrenocorticotropic hormone (ACTH) secretion by corticotroph pituitary neuroendocrine tumors (PitNETs). Magnetic resonance imaging (MRI) is the reference modality for etiological diagnosis but may to visualize small corticotroph microadenomas in up to 30% of the cases, and false positives may occur.\n\nThe study hypothesis is that positron emission tomography (PET) using \\[18F\\]fluoroethyl-L-tyrosine (\\[18F\\]FET) improves localization of ACTH-secreting corticotroph microadenomas compared with MRI and could inform surgical planning and reduce reliance on invasive inferior petrosal sinus sampling.\n\nThis observational cohort (retrospective and prospective data) will assess the diagnostic performance of \\[18F\\]FET PET for tumor localization using postoperative histopathology as the gold standard.\n\nSecondary aims include:\n\n1. assessing cases in which PET modifies localization relative to MRI and is correct by gold standard;\n2. inter-reader agreement between two nuclear medicine physicians;\n3. correlations between PET signal and biochemical markers of hypercortisolism\n4. uni- and multivariable analyses of clinical and imaging parameters influencing PET results;\n5. association between PET findings and subsequent biological remission.",[29,140],"ACTH-producing Pituitary Tumour",[142,143,144,145,146,147,148,149,150],"PET","Cushing disease","[18F]FET","PitNET","Corticotroph adenoma","ACTH","Pituitary","MRI","Amino-acid","2026-03-10",{"date":153,"type":40},"2026-03-11",{"date":155,"type":40},"2023-11-23",{"date":157,"type":22},"2028-11-23",{"name":159,"class":72},"Hospices Civils de Lyon",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":166,"targetDuration":168,"studyType":23,"phases":4,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":46},"100618722","evaluation-of-intraoperative-contrast-enhanced-ultrasound-for-the-identification-of-pituitary-adenoma-in-cushings-disease-compared-to-other-pituitary-tumors-100618722","NCT07335315","Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors","For Contrast Based Protocol:\n\nInclusion Criteria:\n\n* Diagnosis of Cushing disease or required resection for non-corticotroph adenomas\n* Agree to transsphenoidal resection.\n\nExclusion Criteria:\n\n* Patients who are unable to consent (or if their legal guardian\u002Frepresentative decline to consent)\n* Patients who have known or suspected hypersensitivity to microbubble contrast agents or its components such as polyethylene glycol (PEG).\n* Women of child-bearing potential with a positive pregnancy test prior to procedure.\n* Patients who have right to left, bi-directional, or transient right to left cardiac shunts.\n* Patients who have hypersensitivity to perflutren.\n\nFor Non-Contrast Based Protocol:\n\nInclusion Criteria:\n\n* Patients undergoing any pituitary surgery with the study designated neurosurgeons.\n* Patients whose procedures require the use of an intra-operative BK ultrasound without contrast.\n\nExclusion Criteria:\n\n• Patients who are unable to consent (or if their legal guardian\u002Frepresentative decline to consent)",{"count":167,"type":22},110,"6 Months","This pilot and feasibility study aims to combine recent advances in ultrasound imaging, specifically an endonasal transducer array and contrast enhanced ultrasound, to offer an intraoperative image-guided solution for lesion-specific surgical resection to impact clinical outcome. Should this imaging approach help isolate specific lesions and prevent surgical resection of normal pituitary tissue in this first-in-humans study, then the results will provide clinical data for a much larger multi-center clinical trial.",[62,29],"2026-01-05",{"date":173,"type":40},"2026-01-13",{"date":175,"type":40},"2024-06-19",{"date":177,"type":22},"2027-01",{"name":71,"class":72},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":186,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"100313771","collecting-information-about-treatment-results-for-patients-with-cushings-syndrome-100313771","NCT03364803","Collecting Information About Treatment Results for Patients With Cushing's Syndrome","Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study","Inclusion Criteria:\n\n* Age 14 or older\n* Active or treated overt Cushing's (due to pituitary, ectopic, or adrenal tumor), mild adrenal Cushing's syndrome (MACS), or a silent corticotroph tumor\n* The diagnosis of CS or MACS will be made by the PI, based on the below Endocrine Society guidelines, the patient's clinical presentation, and the PI's judgment.\n\n  * Diagnostic criteria for ACTH-dependent Cushing's are according to the Endocrine Society and European Society of Endocrinology guidelines and include: Elevated 24-hour urinary free cortisol (UFC), normal or elevated plasma ACTH, elevated midnight salivary cortisol levels, or classic dexamethasone suppression testing for CD (morning cortisol \\> 5 ug\u002FdL after 1 mg overnight of classic 2-day low dose test) and a pituitary lesion on MRI (in the case of pituitary Cushing's). If patient does not have any of these results, pathology of ACTH tumor may confirm presence of disease.\n  * Diagnostic criterion for MACS is according to the European Society of Endocrinology guidelines: Classic dexamethasone suppression testing for CS (morning cortisol \\>1.8 µg\u002FdL after 1 mg overnight) and the presence of an adrenal adenoma.\n* Silent corticotroph tumors will be defined by surgical pathology demonstrating positivity for ACTH, in the absence of clinical and biochemical features of Cushing's syndrome.\n* In lieu of MRI, surgical, or laboratory reports, physician's assessment note including mention of results will also be used as source for eligibility purposes.\n\nExclusion Criteria:\n\n* Patients with a diagnosis of iatrogenic Cushing's.","14 Years",{"count":188,"type":22},300,"The purpose of this study is to follow participants with Cushing's syndrome during the course of their routine care and to form a data registry to study long term participant outcomes.",[191,113,29],"Cushing's Disease",[113,191,29,193,194],"17-592","Memorial Sloan Kettering Cancer Center","2025-10-22",{"date":197,"type":40},"2025-10-23",{"date":199,"type":40},"2017-11-28",{"date":201,"type":22},"2026-11-28",{"name":194,"class":72},7,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":57,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":46},"100345188","phase-2-multicenter-study-of-seliciclib-r-roscovitine-for-cushing-disease-100345188","NCT03774446","Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease","A Phase 2 Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease","Inclusion Criteria:\n\n* Male and female patients at least 18 years old\n* Patients with confirmed pituitary origin of excess adrenocorticotropic hormone (ACTH) production:\n\n  * Persistent hypercortisolemia established by two consecutive 24-hour UFC assessment ≥1.5× the upper limit of normal\n  * Normal or elevated ACTH levels\n  * Pituitary adenoma (\\>1 cm) on MRI or inferior petrosal sinus sampling (IPSS) central to peripheral ACTH gradient \\>2 at baseline and \\>3 after CRH stimulation\n  * Recurrent or persistent CD defined as pathologically confirmed resected pituitary ACTH-secreting tumor or IPSS central to peripheral ACTH gradient \\>2 at baseline and \\>3 after CRH stimulation, and 24h-UFC \\>ULN beyond post-surgical week 6\n* Patients on medical treatment for Cushing disease. The following washout periods must be completed before screening assessments are performed:\n\n  * Inhibitors of steroidogenesis: metyrapone, ketoconazole: 2 weeks; Levoketoconazole: 3 weeks; osilodrostat: 6 weeks\n  * Somatostatin receptor ligand pasireotide: short-acting, 2 weeks; long-acting, 4 weeks\n  * Progesterone receptor antagonist mifepristone: 2 weeks\n  * Dopamine agonist cabergoline: 4 weeks\n  * Patients treated with CYP3A or CYP2B6 strong inducers or inhibitors, including those listed below. Required washout time varies between drugs; minimum 5-6 times the half-life of the drug.\n\n    * Strong CYP3A inducers: apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's wort\n    * Moderate CYP3A inducers: bosentan, efavirenz, etravirine, phenobarbital, primidone\n    * Weak CYP3A inducers: armodafinil, modafinil, rufinamide\n    * Strong CYP2B6 inducer: carbamazepine\n    * Moderate CYP2B6 inducers: efavirenz, rifampin\n    * Weak CYP2B6 inducers: nevirapine, ritonavir\n    * Strong CYP3A inhibitors: boceprevir, cobicistat, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and ritonavir and (ombitasvir and\u002For dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, telaprevir, tipranavir and ritonavir, telithromycin, troleandomycin, voriconazole, clarithromycin, idelalisib, nefazodone, nelfinavir.\n    * Moderate CYP3A inhibitors: aprepitant, ciprofloxacin, conivaptan, crizotinib, cyclosporine, diltiazem, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, verapamil\n    * Strong CYP2B6 inhibitor: ticlopidine\n\nExclusion criteria:\n\n* Patients with compromised visual fields, and not stable for at least 6 months\n* Patients with abutment or compression of the optic chiasm on MRI and normal visual fields\n* Patients with Cushing's syndrome due to non-pituitary ACTH secretion\n* Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia\n* Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e., Carney Complex, McCune-Albright syndrome, Multiple endocrine neoplasia (MEN) 1\n* Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)\n* Patients with cyclic Cushing's syndrome defined by any measurement of UFC over the previous 1 months within normal range\n* Patients with pseudo-Cushing's syndrome, i.e., non-autonomous hypercortisolism due to overactivation of the hypothalamic-pituitary-adrenal (HPA) axis in uncontrolled depression, anxiety, obsessive compulsive disorder, morbid obesity, alcoholism, and uncontrolled diabetes mellitus\n* Patients who have undergone major surgery within 1 month prior to screening\n* Patients with serum K+\\\u003C 3.5 while on replacement treatment\n* Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C \\>8%\n* Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, high grade atrioventricular (AV) block, history of acute MI less than one year prior to study entry\n* Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with abnormal alanine transferase (ALT) or aspartate aminotransferase (AST) at screening or patients with advanced liver fibrosis (≥10 kPa) on elastography at screening\n* Patients with estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m2\n* Patients not biochemically euthyroid\n* Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results, such as\n\n  * History of immunocompromise, including a positive HIV test result (ELISA and Western blot). An HIV test will not be required, however, previous medical history will be reviewed\n  * Presence of active or suspected acute or chronic uncontrolled infection\n  * History of, or current alcohol misuse\u002Fabuse in the 12 month period prior to screening\n* Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. If a woman is participating in the trial then one form of contraception is sufficient (pill or diaphragm) and the partner should use a condom. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to screening and must agree to continue the oral contraceptive throughout the course of the study and for 3 months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three months afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs)\n* Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or patients who have previously been treated with seliciclib\n* Patients with any ongoing or likely to require additional concomitant medical treatment to treat CD\n* Patients who have received pituitary irradiation within the last 5 years prior to the baseline visit\n* Patients who have been treated with radionuclide at any time prior to study entry\n* Patients with known hypersensitivity to seliciclib\n* Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study\n* Patients with hepatitis B surface antigen (HbsAg) positivity\n* Patients with hepatitis C antibody (anti-HCV) positivity\n* Patients with prolonged QTcF on screening electrocardiogram (QTcF \\>450 msec)",{"count":212,"type":22},13,[110],"This phase 2 multicenter, open-label clinical trial will evaluate safety and efficacy of 4 weeks of oral seliciclib in patients with newly diagnosed, persistent, or recurrent Cushing disease.\n\nFunding Source - FDA Office of Orphan Products Development (OOPD)",[29],[143,217,218],"R-roscovitine","Seliciclib","2025-09-09",{"date":221,"type":40},"2025-09-11",{"date":223,"type":40},"2018-11-02",{"date":225,"type":22},"2026-08",{"name":227,"class":72},"Cedars-Sinai Medical Center",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":57,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":46},"100513921","phase-2-fimepinostat-combination-hdac-and-pi3-kinase-inhibitor-tumor-directed-therapy-for-cushing-disease-100513921","NCT05971758","Fimepinostat, Combination HDAC and Pi3-kinase Inhibitor Tumor-Directed Therapy for Cushing Disease","Inclusion Criteria:\n\n* Male and female patients at least 18 years old\n* Patients with confirmed pituitary origin Cushing syndrome defined as 1, 2\\& 3 or 4 \\& 5 below:\n\n  1. Persistent hypercortisolism defined as a mean of 3 consecutive 24h UFC at baseline assessment ≥ 1.3x ULN\n  2. Normal or elevated plasma ACTH levels\n  3. Pituitary adenoma \\> 4mm visible on MRI or inferior petrosal sinus sampling (IPSS) central to peripheral ACTH gradient \\>2 at baseline and\u002For \\>2 after DDAVP stimulation.\n  4. Recurrent or persistent CD defined as pathologically confirmed previously resected pituitary ACTH-secreting tumor, and 24 hour UFC \\>ULN at least 4 weeks after pituitary surgery.\n  5. Patients on medical treatment for CD. Washout periods will be completed as below before screening: Inhibitors of steroidogenesis (metyrapone, ketoconazole, osilodristat,\n\n     * Levo-ketoconazole): 2 weeks\n     * SRLs (pasireotide): 2 weeks\n     * Progesterone receptor antagonist (mifepristone): 2 weeks\n     * Dopamine agonists (cabergoline): 4 weeks\n     * CYP3A4 strong inducers or inhibitors: varies between drugs; minimum 5-6 times the half-life of drug\n\nExclusion Criteria:\n\n* Patients with compromised visual fields, or evidence of visual changes within past 6 months\n* Patients with sellar tumor abutting or compressing the optic chiasm on MRI and normal visual fields\n* Patients with Cushing's syndrome not due to an ACTH-secreting pituitary tumor\n* Patients who have undergone major surgery including pituitary surgery within 1 month of screening or who have any major surgical procedures planned across the study period\n* Patients with serum potassium \\\u003C 3.5 mEq\u002FL unless stably controlled on potassium supplementation\n* Patients with poorly-controlled Diabetes mellitus evidenced by HbA1c levels \\>8\n* Patients with poorly controlled hypertension (i.e. blood pressure ≥ 160\u002F100 mm Hg)\n* Patients who have clinically significant cardiovascular impairment, as evidenced by the presence of bradycardia, ventricular tachycardia, history of myocardial infarction within past year, or any other cardiovascular impairment that may pose significant health risk in view of the investigator.\n* Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with ALT or AST \\>1.5 x ULN, serum total bilirubin \\>ULN, serum albumin \\\u003C0.67 x LLN at screening\n* Patients with renal disease or history of renal disease with creatinine clearance of 30 cm3\u002Fmin or less and\u002For creatinine \\> 1.5 mg\u002Fdl at screening\n* Patients not biochemically euthyroid. Patients receiving thyroid-replacement therapy must be on a stable dose for at least 3 months.\n* Patients who are known to be positive for HIV, or any other condition that significantly compromises subject's immune system.\n* History of alcohol abuse or illicit substance use within past year.\n* Female patients who are pregnant or lactating or are of childbearing potential unless willing to practice acceptable method of birth control. Women participating in the trial must employ double barrier method through oral contraceptive or diaphragm with partner utilizing a condom. Abstinence is an acceptable form of birth control if routinely practiced. Male participants must utilize a condom with spermicidal cap\u002Fjelly and agree to not donate sperm for up to 3 months beyond main study period.\n* Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or within 5 half-lives of the investigational treatment whichever is longer.\n* Patients with concomitant treatment of strong CYP3A4 inducers or inhibitors.\n* Patients who have received pituitary irradiation within the last 5 years prior to the baseline visit\n* Patients with known hepatitis B surface antigen (HbsAg) positivity\n* Patients with known hepatitis C antibody (anti-HCV) positivity",{"count":137,"type":22},[110],"Supported by the pre-clinical data (summarized in Research Strategy), the investigators propose that Fimepinostat is an ideal candidate drug in the treatment and intervention of patients with Cushing Disease. The investigators propose a pilot, short-term (4 weeks) phase II single-center study to demonstrate the safety and efficacy of Fimepinostat in the treatment of patients with de novo, persistent, and\u002For recurrent CD recruited at the University of California, Los Angeles. The trial will have a 2-arm design and will simultaneously examine two different doses of Fimepinostat. The study will allow the investigators to determine the efficacy and safety of these doses in the treatment of CD and guide dose selection for subsequent, larger studies. Funding Source - FDA OOPD.",[29],"2025-07-01",{"date":240,"type":40},"2025-07-04",{"date":242,"type":40},"2025-01-16",{"date":244,"type":22},"2029-01",{"name":246,"class":72},"University of California, Los Angeles"]