An Open Study of the Efficacy, Durability, and Safety of a new drug in Patients with Bladder Cancer (ATLAS)

Phase 1

• Conditions: on-Muscle Invasive Bladder Cancer; MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003541-11-BG
• Lead Sponsor: roGen Pharma Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-12
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 632

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 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

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified