- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05136898
Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC)
A Phase 3b, Open-Label, Single-Arm, Multicenter Study to Assess the Feasibility of Home Instillation of UGN-102 for Treatment of Patients With Low-Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Homewood, Alabama, United States, 35209
- Urology Centers of Alabama (UCA)
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University School of Medicine
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North Carolina
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Greensboro, North Carolina, United States, 27408
- Medication Management
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Tennessee
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Nashville, Tennessee, United States, 37209
- Urology Associates, P.C.
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Virginia
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Richmond, Virginia, United States, 23235
- Virginia Urology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) 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:
- presence of multiple tumors.
- solitary tumor > 3 cm.
- recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial Screening Visit).
- Negative voiding cytology for high-grade (HG) disease within 6 weeks before Screening.
Has adequate organ and bone marrow function as determined by routine laboratory tests as below:
- Leukocytes ≥ 3,000/μL (≥ 3×10^9/L).
- Absolute neutrophil count ≥ 1,500/μL (≥ 1.5×10^9/L).
- Platelets ≥ 100,000/μL (≥ 100×10^9/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.
- Has no evidence of active urinary tract infection (UTI) 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.
- Has an anticipated life expectancy of at least the duration of the trial.
Exclusion Criteria:
- Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.
- 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:
- neurogenic bladder.
- active urinary retention.
- any other condition that would prohibit normal voiding.
- Past or current T1 UC, muscle invasive UC (ie, T2, T3, T4), metastatic UC, or concurrent upper tract urothelial carcinoma (UTUC).
- 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 transurethral resection of bladder tumors (TURBT).
- Has participated in a study with an investigational agent or device within 30 days of enrollment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: UGN-102
Patients will receive 6 once-weekly intravesical instillations of UGN-102.
Treatment Visit 1 will occur at the investigative site and instillation will be performed by a qualified physician.
Treatment Visits 2 to 6 will occur at the patient's home and instillation will be performed by a properly trained and qualified home health professional.
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UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder. The UGN-102 admixture for intravesical instillations contains 75 mg mitomycin in 56 mL admixture (1.33 mg mitomycin per 1 mL).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, discontinuations from at home study treatment, and abnormal clinical laboratory tests (hematology, serum chemistry, and urinalysis).
Time Frame: up to 3 months
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The number of patients with each type of event will be summarized.
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up to 3 months
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Feasibility questionnaires
Time Frame: up to 3 months
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Home instillation feasibility questionnaires will be completed by the patient, the home health professional, and the Investigator. Patients will rate their home instillation experience such as comfort, safety/concerns, communication, preference compared to office instillation, and overall experience at each home instillation visit. Patient recommendations regarding home instillation will be collected at the 3-month Visit. Home health professionals will rate their home instillation experience such as comfort, difficulty, concerns, and support with performing the instillation at each home instillation visit. Investigators will provide their feedback on home instillation compared to office instillation, taking into account the experiences of the patient and home health professional, at the 3-month Visit. Data will be summarized descriptively and feasibility of home instillation will be assessed based on the totality of the data. |
up to 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response rate (CRR)
Time Frame: 3 months
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CRR is defined as the percentage of patients who achieved CR at the 3-month disease assessment.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sunil Raju, MBBS, UroGen Pharma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Non-Muscle Invasive Bladder Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Alkylating Agents
- Antibiotics, Antineoplastic
- Mitomycins
- Mitomycin
Other Study ID Numbers
- BL010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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UroGen Pharma Ltd.TerminatedBladder Cancer | Urothelial Carcinoma Bladder | Urothelial CarcinomaUnited States, Israel, Russian Federation, Georgia, Bulgaria, Estonia, Latvia, Poland, Serbia, Ukraine
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UroGen Pharma Ltd.RecruitingBladder Cancer | Non-muscle Invasive Bladder Cancer | Urothelial Carcinoma Bladder | NMIBC | Urothelial Carcinoma Recurrent | Carcinoma in Situ of BladderUnited States, Italy, Spain
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Neothetics, IncCompleted
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UroGen Pharma Ltd.WithdrawnCarcinoma | Transitional Cell Carcinoma | Transitional Cell Cancer of the Renal Pelvis and UreterIsrael, United States
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CinDome Pharma, Inc.CompletedGastroparesisUnited States
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Orion Corporation, Orion PharmaCompleted
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