A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) - CELC-G-301

Celcuity Inc.0 个研究点目标入组 701 人开始时间: 2022年12月21日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Celcuity Inc.
入组人数: 701

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Adults =18 years of age and meet one of the following criteria: a. Women who are postmenopausal, defined as one of the following: i. Women 18–59 years of age (at the time of consent) with cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory’s reference range for postmenopausal females ii. Women =60 years of age (at the time of consent) with cessation of menses for at least 12 consecutive months iii. Documented bilateral oophorectomy iv. Medically confirmed ovarian failure b. Pre/perimenopausal women with medically-induced menopause by treatment with the luteinizing hormone-releasing hormone (LHRH) agonist goserelin, the gonadotropin releasing hormone (GnRH) agonist leuprolide (Lupron Depot), or equivalent agents to induce chemical menopause c. Male subjects must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatment, Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI), Resolution of all toxicities related to prior therapies or surgical procedures to NCI CTCAE v.5.0 Grade =1 (except alopecia), Left ventricular ejection fraction =50% at baseline, At least 2 weeks beyond treatment with a targeted therapy, hormonal therapy, or major surgery and at least 3 weeks beyond immunotherapy and/or radiation therapy and recovered from all acute toxicities prior to randomization (adverse events [AEs] from prior anticancer agents recovered to Grade =1 or lower; except alopecia), Adequate bone marrow, hepatic, renal and coagulation function as defined by the following: a. Absolute neutrophil count =1.5 × 109/L (maintained without growth factor support within 7 days of C1D1) b. Hemoglobin =9.0 g/dL (90 g/L) (maintained without transfusion support within 7 days of C1D1) c. Platelets =100 × 109/L d. HbA1c =6.4% and fasting plasma glucose (FPG) =140 mg/dL e. Potassium within normal limits, or corrected with supplements f. Calcium (corrected for serum albumin) and magnesium within normal limits or Grade =1 if judged clinically not significant by the Investigator g. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 × upper limit of normal (ULN) (if no hepatic metastases); if hepatic tumor involvement, AST and ALT =5 × ULN h. Total bilirubin =1.5 × ULN (total bilirubin=3.0 × ULN and direct bilirubin =1.5 × ULN in patients with Gilbert’s Syndrome) i. Serum amylase =1.5 × ULN (subjects with values >1.5 × ULN may be allowed if there are no clinical and radiological signs of pancreatitis) j. Serum lipase =1.5 × ULN (subjects with values >1.5 × ULN may be allowed if there are no clinical and radiological signs of pancreatitis) k. Prothrombin time (PT)/International Normalized Ratio (INR) =1.5 × ULN if not on anticoagulants l. Calculated creatinine clearance (CrCL) >50 mL/min using the Cockcroft and Gault equation, Must be willing and able to comply with protocol-specified schedules of assessments, treatment plans, laboratory tests, and other study procedures, Ability to understand the investigational nature of the study and sign the informed consent, Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year (2 years f

排除标准

•History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for =3 years, History of drug induced pneumonitis or interstitial lung disease, Subjects that, in the opinion of the Investigator, are unable to undertake study therapy or comply with study requirements a. Current uncontrolled medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results b. Where applicable per country regulation, the subject must not currently be committed to an institution by virtue of an order issued either by judicial or administrative authorities, Prior treatment with a phosphoinositide 3 kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor, Pregnant or breast-feeding women, Concurrent participation in another interventional clinical trial a. Subjects must agree not to participate in another clinical trial (other than observational trials) at any time during participation in VIKTORIA-1, Prior treatment with chemotherapy and antibody drug conjugates (e.g., Enhertu®) for advanced disease is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted). Subjects whose disease progressed to metastatic or advanced within less than 6 months of completing adjuvant or neoadjuvant therapy will be considered as having received chemotherapy for advanced disease., More than 2 lines of prior endocrine therapy treatment for metastatic or locally advanced breast cancer., Bone only disease that is only blastic with no soft tissue component, Subjects with type 1 diabetes or uncontrolled type 2 diabetes, Active human immunodeficiency virus (HIV) infection. a. Subjects with well controlled HIV infection may be allowed if CD4+ T-cell (CD4+) counts >350 cells/µL b. Subjects without a history of AIDS-defining opportunistic infections may be eligible for enrollment, Known and untreated, or active, brain or leptomeningeal metastases a. 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 enrollment, Known seropositive for or active viral infection with hepatitis B virus a. Hepatitis B surface antigen (HBsAg) positive b. HBsAg negative, hepatitis B surface antibody (anti-HBs) positive and/or hepatitis B core antibody (anti-HBc) positive and detectable viral DNA by PCR [Note: Subjects who are HBsAg negative and viral DNA PCR negative are eligible.], Known seropositive for, or active infection with hepatitis C virus a. Subjects with positive hepatitis C virus (HCV) antibodies are eligible with negative PCR test for HCV, Medical history or concurrent conditions that are contraindicated for investigational treatments in this study (alpelisib) a. Active osteonecrosis of the jaw from previous or concurrent treatment with bisphosphonates/denosumab b. History of severe cutaneous reactions (e.g., Stevens-Johnson syndrome), Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term, History of clinically significant cardiovascular abnormalities

研究者

发起方

Celcuity Inc.

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