[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Celcuity Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100574311","phase-3-phase-3-study-of-gedatolisib-as-first-line-treatment-for-patients-with-hr-positive-her2-negative-advanced-breast-cancer-viktoria-2-100574311",false,"NCT06757634","Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)","VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+\u002FHER2- breast cancer\n2. Adult females, pre- and\u002For post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue for the duration of the study.\n3. Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment.\n4. Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of completing (neo)adjuvant ET.\n5. Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.\n6. Permitted prior therapies:\n\n   1. (neo)adjuvant fulvestrant only if the treatment duration \\\u003C 6 months\n   2. (neo)adjuvant chemotherapy\n   3. (neo)adjuvant CDK4\u002F6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4\u002F6i\n\n   i. Study 1: if disease progression was on or within event occurred \\>6 months of discontinuation after completion of CDK4\u002F6 inhibitor portion of treatment.\n\n   ii. Study 2: if disease progression event occurred \\>12 months after completion of CDK4\u002F6 inhibitor portion of treatment.\n7. Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with nonmeasurable bone-only disease are not eligible. Patients with bone-only disease that has lytic or mixed lytic\u002Fblastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n9. Life expectancy of at least \\>6 months.\n10. Adequate bone marrow, hepatic, renal and coagulation function.\n\nExclusion Criteria:\n\n1. Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study.\n2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor or any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting.\n3. Prior treatment with systemic anticancer therapy for ABC\n4. Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy.\n5. Known and untreated, or active, brain or leptomeningeal metastases\n6. History of clinically significant cardiovascular abnormalities\n7. Known, clinically significant ophthalmic conditions\n8. History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis","ALL","18 Years",{"count":19,"type":20},1180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+\u002FHER2- advanced breast cancer.",[26],"Breast Cancer",[28,29,30,31,32,33,34],"Breast Cancer, Advanced or Metastatic","Gedatolisib","HR Positive","ER Positive","HER2 Negative","PIK3CA MT","PI3K","RECRUITING","2026-05-14",{"date":38,"type":39},"2026-05-18","ACTUAL",{"date":41,"type":39},"2025-07-24",{"date":43,"type":20},"2033-07-30",{"name":45,"class":46},"Celcuity Inc","INDUSTRY",203,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":61,"conditions":62,"keywords":69,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100530754","phase-1-gedatolisib-in-combination-with-darolutamide-in-metastatic-castration-resistant-prostate-cancer-100530754","NCT06190899","Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer","A Phase 1\u002F2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria\n\n1. Adult males ≥18 years of age\n2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with \\\u003C10% neuroendocrine type cells\n3. Subjects must have metastatic castration-resistant prostate cancer (mCRPC; i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy)\n4. Metastatic disease identified by conventional imaging: computed tomography (CT), magnetic resonance imaging (MRI), or technetium 99m-methyl diphosphonate (99mTc-MDP) bone scintigraphy. Measurable and non-measurable disease are allowed, but metastases visible only on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) will not be allowed for eligibility purposes.\n5. Progressive mCRPC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria as defined by at least one of the following criteria:\n\n   5.1. Prostate-specific antigen (PSA) progression defined as a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination. A minimum PSA of 1.0 ng\u002FmL is required for study entry.\n\n   5.2. Soft-tissue progression defined as an increase ≥20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 5.3. Progression of bone disease (measurable disease) or 2 or more new bone lesions by bone scan.\n6. Continued primary androgen deprivation with luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) if the subject has not undergone bilateral orchiectomy\n7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1\n8. Progression during treatment with one next-generation androgen receptor signaling inhibitor for metastatic disease (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)\n9. Completion of prior treatment with an androgen receptor inhibitor (ARi) ≥4 weeks before the first dose of the study drug\n10. At least 2 weeks beyond treatment with a targeted therapy or major surgery and at least 3 weeks beyond any other systemic anticancer therapy and\u002For radiation therapy, and resolution of all toxicities related to prior therapies or surgical procedures to baseline (except alopecia, Grade 1 peripheral neuropathy)\n11. Adequate bone marrow, hepatic, renal and coagulation function\n\nExclusion Criteria\n\n1. History of malignancies other than adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥3 years\n2. Adenocarcinoma of the prostate with a small cell component, and with ≥10% neuroendocrine type cells\n3. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (AKT) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor\n4. Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide).\n5. Subjects with uncontrolled type 1 or type 2 diabetes\n\n9\\. Known and untreated, or active, brain or leptomeningeal metastases. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to randomization 10. History of clinically significant cardiovascular abnormalities 11. Gastrointestinal tract disease resulting in an inability to absorb oral medication as well as history of inflammatory bowel disease 12. Unable to swallow oral medication tablets\u002Fcapsules","MALE",{"count":57,"type":20},54,[59,60],"PHASE1","PHASE2","This is a Phase 1\u002F2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.",[63,64,65,66,67,68],"mCRPC (Metastatic Castration-resistant Prostate Cancer)","Genital Diseases, Male","Urogenital Diseases, Male","Prostatic Disease","Prostatic Neoplasms, Castration-Resistant","Prostate Cancer",[29,34,70,71,72,68,67,66,65,64],"Protein Kinase Inhibitors","mCRPC (metastatic castration-resistant prostate cancer)","Darolutamide","2026-04-07",{"date":75,"type":39},"2026-04-13",{"date":77,"type":39},"2024-01-01",{"date":79,"type":20},"2030-01",{"name":45,"class":46},13,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":89,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":98,"locationsCount":99},"100449625","expanded-access-protocol-for-subjects-previously-treated-with-gedatolisib-in-b2151009-100449625","NCT05134922","Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009","Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)","Inclusion Criteria:\n\n1. Currently enrolled in the B2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the Investigator\n2. Previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures\n3. No evidence of progressive disease, as determined by the Investigator\n4. Provide written informed consent prior to enrolling and receiving treatment\n\nExclusion Criteria:\n\n1. Permanently discontinued from treatment in Study B2151009, or discontinued from Study B2151009 for any reason\n2. Women who are pregnant, intend to become pregnant, or nursing","FEMALE","EXPANDED_ACCESS","Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.",[93],"Breast Neoplasm Malignant Female","AVAILABLE","2025-03-19",{"date":97,"type":39},"2025-03-21",{"name":45,"class":46},5,""]