Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive B… (NCT05136898) | Clinical Trial Compass
CompletedPhase 3
Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)
United States8 participantsStarted 2021-11-30
Plain-language summary
This study aims to demonstrate that home instillation of UGN-102 is a feasible alternative to instillation in a clinical setting, which might mitigate patient challenges (logistical, expense, and comfort) when receiving treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.
✓. Patient who has newly diagnosed or historic LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.
✓. Has IR disease, defined as having 1 or 2 of the following:
✓. Negative voiding cytology for HG disease within 6 weeks before Screening.
✓. Has adequate organ and bone marrow function as determined by routine laboratory tests:
✓. Has no evidence of active urinary tract infection at the Screening and baseline visits.
✓. Patient is willing to receive instillations of UGN-102 at home (ie, Treatment Visits 2 to 6) by an appropriately trained home health professional.
✓. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from first instillation through 6 months post treatment. Acceptable methods of birth control that are considered to have a low failure rate (ie, less than 1% per year) when used consistently and correctly include implants, injections, combined (estrogen/progesterone) oral contraceptives, intrauterine devices (only hormonal), condoms with spermicide, sexual abstinence, or vasectomized partner.
Exclusion criteria
What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs of Special Interest.
Timeframe: Up to 3 months
2
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory Values
Timeframe: Up to 3 months
3
Composite Score for the Post-instillation Patient Questionnaire
Timeframe: Up to 5 weeks
4
Responses to the Post-instillation Home Health Professional Questionnaire
Timeframe: Up to 5 weeks
5
Responses to End of Study Patient and Investigator Questionnaires
✕. History of HG bladder cancer (papillary or carcinoma in situ) in the past 2 years.
✕. Known allergy or sensitivity to mitomycin that in the investigator's opinion cannot be readily managed.
✕. Clinically significant urethral stricture that would preclude passage of a urethral catheter.
✕. History of:
✕. Past or current T1 UC, muscle invasive UC (ie, T2, T3, T4), metastatic UC, or concurrent upper tract UC.
✕. 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.
✕. 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.