Non-Muscle Invasive Bladder Cancer MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
UroGen Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 × 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
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of UGN-102 with or without TURBT versus TURBT alone with respect to disease-free survival (DFS) in patients with Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR-NMIBC).;Secondary Objective: 1. To evaluate the efficacy of UGN-102 with or without TURBT versus TURBT alone with respect to: a) Time to Recurrence (TTR) b) Complete Response Rate (CRR) at 3-Month disease assessment c) Duration of Response (DOR) d) Avoidance of surgery (TURBT) for treatment of LG IR-NMIBC 2. To evaluate the safety profile of UGN-102 with or without TURBT versus TURBT alone. 3. To assess the effect of UGN-102 with or without TURBT versus TURBT alone on Patient Reported Outcomes (PROs) including disease related symptoms, functioning, and health-related quality of life (HRQoL). 4. To evaluate visit level Complete Response Rate (CRR);Primary end point(s): Disease-free survival (DFS) is defined as the time from randomization until the earliest date of any of the following events: • Failure to be rendered free of local disease at the 3-Month assessment after the TURBT procedure. • Recurrence of low-grade disease afterthe 3-Month assessment (i.e., during the follow-up period). • Progression to high-grade disease. • Death due to any cause;Timepoint(s) of evaluation of this end point: Up until End of Study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The following efficacy endpoints will be evaluated: a) Time to recurrence (TTR) is defined as the time from randomization until the earliest date of recurrence of low-grade disease or progression to high-grade disease. b) Complete response rate (CRR), defined as the proportion of patients who achieved CR at the 3-Month disease assessment. c) Duration of response (DOR), defined as the time from first documented CR until the earliest date of any of the following events: • Recurrence of low-grade disease. • Progression to high-grade disease. • Death due to any cause d) Proportion of patients requiring TURBT in each arm and average number of TURBT interventions per patient in each arm 2. The safety profile of UGN-102 and TURBT will be evaluated as assessed through standard clinical and laboratory tests (hematology and chemistry, urinalysis, physical examination, vital sign measurements, diagnostic tests, etc.) and through the collection of reports of adverse events (AEs) and serious adverse events (SAEs) including AEs of special interest. 3. Changes from baseline in HRQoL measures assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Non-muscle Invasive Bladder Cancer patients (EORTC-QLQ-NMIBC24). 4. Observed CRR at scheduled disease assessment timepoints, defined as the proportion of patients who had CR at 3-Month disease assessment and maintained CR up to that particular follow-up disease assessment.;Timepoint(s) of evaluation of this end point: Up until End of Study. | — |
Countries
Bulgaria, Estonia, Georgia, Israel, Latvia, Poland, Romania, Russian Federation, Serbia, Ukraine, United States
Contacts
Public ContactMedical Officer
PSI CRO AG
Outcome results
None listed