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    Summary
    EudraCT Number:2021-005948-29
    Sponsor's Protocol Code Number:BL011
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-29
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLithuania - SMCA
    A.2EudraCT number2021-005948-29
    A.3Full title of the trial
    A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients with Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open Study of the Efficacy and Safety of a new drug in Patients with Bladder Cancer
    A.3.2Name or abbreviated title of the trial where available
    A Phase 3 Single-Arm Study of UGN-102 for Treatment of LG IR NMIBC
    A.4.1Sponsor's protocol code numberBL011
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUroGen Pharma Ltd.
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUroGen Pharma Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPSI CRO AG
    B.5.2Functional name of contact pointProject management
    B.5.3 Address:
    B.5.3.1Street Address3 Novovokzalna St
    B.5.3.2Town/ cityKyiv
    B.5.3.3Post code03038
    B.5.3.4CountryUkraine
    B.5.4Telephone number+38044492 8560
    B.5.6E-mailyaroslav.moskalyuk@psi-cro.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUGN-102 (Mitomycin) for Solution
    D.3.2Product code UGN-102
    D.3.4Pharmaceutical form Powder for intravesical solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMITOMYCIN
    D.3.9.1CAS number 50-07-7
    D.3.9.2Current sponsor codeUGN-102
    D.3.9.4EV Substance CodeSUB09006MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Muscle Invasive Bladder Cancer
    E.1.1.1Medical condition in easily understood language
    Bladder Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the tumor ablative effect of UGN-102 in patients with LG NMIBC (Low Grade Non-Muscle-Invasive Bladder Cancer).
    E.2.2Secondary objectives of the trial
    1. To evaluate the durability of response with respect to DOR
    2. To evaluate the durability of response with respect to DCR rate at scheduled disease assessment time points and DFS
    3. To evaluate the safety and tolerability of intravesical instillations of UGN-102 in patients with LG NMIBC
    E.2.3Trial contains a sub-study No
    E.3Principal 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).
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Complete Response Rate (CRR), defined as the proportion of patients who achieved CR at the 3-month Visit (3 months after the first instillation of UGN-102) as determined by cystoscopy, for cause biopsy, and urine cytology
    E.5.1.1Timepoint(s) of evaluation of this end point
    No formal interim analysis is planned for this study. The actual time point of the primary analysis will be determined based on the emerging data. The EOS analysis will be performed after all patients complete the study, are withdrawn from the study, are lost to follow-up,or when the study is closed by the Sponsor. Primary results of all relevant endpoints will be updated using the final data.
    E.5.2Secondary end point(s)
    1. Duration of response in patients who achieved CR at the 3-month Visit, defined as the time from the date of evidence of CR at the 3-month Visit to the earliest date of recurrence or progression as determined using the date of cystoscopy, for cause biopsy, or cytology, or death due to any cause, whichever occurred first
    2. Durable complete response rate at scheduled disease assessment time points, defined as the proportion of patients who achieved CR at the 3-month Visit and maintained CR (ie, no detectable disease) up to that particular follow-up disease assessment
    3. Disease-free survival in patients who achieved CR at the 3-month Visit, defined as the time from first dose to the earliest date of recurrence or progression as determined using the date of cystoscopy, for cause biopsy, or cytology, or death due to any cause, whichever occurred first
    4. The safety profile of UGN-102 will be evaluated through the reporting of AEs, including SAEs and AESIs, and through standard clinical and laboratory tests (eg, hematology and chemistry, urinalysis, physical examination, and vital signs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    No formal interim analysis is planned for this study. The actual time point of the primary analysis will be determined based on the emerging data. The EOS analysis will be performed after all patients complete the study, are withdrawn from the study, are lost to follow-up,or when the study is closed by the Sponsor. Primary results of all relevant endpoints will be updated using the final data.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    Austria
    Estonia
    Latvia
    Lithuania
    Poland
    Bulgaria
    Spain
    Georgia
    Serbia
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 132
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 179
    F.4.2.2In the whole clinical trial 220
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
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