A Randomized, Controlled, Open-label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients with Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR-NMIBC) (ATLAS) - A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer(ATLAS)

roGen Pharma Ltd.0 个研究点目标入组 632 人开始时间: 2021年1月12日最近更新: 2022年4月19日

试验速览

暂无简介。

•1. Patient who has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 8 weeks of screening;
•2. Is at intermediate risk for progression, defined as having 1 or 2 of the following:
•a. presence of multiple tumors
•b. solitary tumor > 3 cm
•c. recurrence (= 1 occurrence of LG NMIBC within 1 year of the current diagnosis at initial Screening Visit)
•3. Negative voiding cytology for high grade (HG) disease within 6 weeks of screening;
•4. Has adequate organ and bone marrow function as determined by routine laboratory tests as below:
•Leukocytes = 3,000/µL (= 3×109/L)
•Absolute neutrophil count = 1,500/µL (= 1.5×109/L)
•Platelets = 100,000/µL (= 100×109/L)
•Hemoglobin = 9.0 g/dL
•Total bilirubin = 1.5 x upper limit of normal (ULN)
•Aspartate aminotransferase (AST) (Serum glutamic oxaloacetic transaminase [SGOT])/Alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase [SGPT]) = 2.5 × ULN
•Alkaline phosphatase (ALP) = 2.5 × ULN
•Estimated glomerular filtration rate (eGFR) = 30 mL/min;
•5. Has no evidence of active urinary tract infection (UTI);
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 253
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 379

•1. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment;
•2. Received Bacille de Calmette et Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year;
•3. History of HG papillary UC in the past 2 years;
•4. History of:
•a. neurogenic bladder
•b. active urinary retention
•c. any other condition that would prohibit normal voiding
•5. Past or current muscle invasive (i.e., T2, T3, T4) or metastatic UC or concurrent upper tract urothelial carcinoma (UTUC);
•6. Current tumor grading of T1;

发起方

roGen Pharma Ltd.