An Open Study of the Efficacy and Safety of a new drug in Patients with Bladder Cancer

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: EUCTR2021-005948-29-AT

Lead Sponsor: roGen Pharma Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 220

Inclusion Criteria

1. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
2. Patient must be = 18 years of age at the time of signing the ICF.
3. Patient who has LG NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.
4. History of LG NMIBC requiring treatment with TURBT. Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened.
5. Has intermediate risk disease, defined as having 1 or 2 of the following:
a. Presence of multiple tumors.
b. Solitary tumor > 3 cm.
c. Early or frequent recurrence (= 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial Screening Visit).
6. Negative voiding cytology for HG disease within 8 weeks before Screening.
7. 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)/Alanine aminotransferase (ALT) = 2.5 × ULN.
• Alkaline phosphatase (ALP) = 2.5 × ULN.
• Estimated glomerular filtration rate (eGFR) = 30 mL/min.
8. Has an anticipated life expectancy of at least the duration of the trial.

9. Both male and female patients:
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
a. Female partner of male patient:
Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the female partner is of childbearing potential (defined as premenopausal women who have not been sterilized).
Acceptable methods of birth control which are considered to have a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as implants, injectable, combined (estrogen/progesterone) oral contraceptives, intrauterine devices
(only hormonal), condoms with spermicide, sexual abstinence* or vasectomized partner.
* Sexual abstinence is defined as refraining from intercourse from enrollment through 6 months post treatment. Periodic abstinence (calendar, symptothermal, postovulation methods) is NOT an acceptable method of contraception.
b. Female patient:
Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the patient is of childbearing potential (defined as
premenopausal women who have not been sterilized).
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 88
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132

Exclusion Criteria

1. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.
2. History of HG bladder cancer (papillary or carcinoma in situ [CIS]) in the past 2 years.
3. Known allergy or sensitivity to mitomycin that in the Investigator’s opinion cannot be readily managed.
4. Clinically significant urethral stricture that would preclude passage of a urethral catheter.
5. History of:
a. Neurogenic bladder.
b. Active urinary retention.
c. Any other condition that would prohibit normal voiding.
6. Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC
7. Current tumor grading of T1
8. Concurrent upper tract urothelial carcinoma (UTUC).
9. Evidence of active urinary tract infection (UTI) that in the Investigator’s opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment.
10. Is pregnant or breastfeeding.
11. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the Investigator, the patient would be unable to comply with the protocol.
12. History of prior treatment with an intravesical chemotherapeutic agent in the past 2 years except for a single dose of chemotherapy immediately after any previous TURBT.
13. Has participated in a study with an investigational agent or device within 30 days of enrollment.
14. Has previously participated in a study in which they received UGN-102.
15. Has any other active malignancy requiring treatment with systemic anticancer therapy (eg, chemotherapy, immunotherapy, radiation therapy). Superficial cancers such as cutaneous
basal cell or squamous cell carcinomas that can be treated locally are allowed
16. Has any other clinically significant medical or surgical condition that in the Investigator’s opinion could compromise patient safety or the interpretation of study results

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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