Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT03558503
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2018-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elyse.seltzer@urogen.com', 'phone': '1-646-492-8518', 'title': 'Elyse Seltzer, MD', 'organization': 'UroGen Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 57, 'seriousNumAtRisk': 63, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 26}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 13}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pruritus genital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vulvovaginal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Accidental exposure to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Acute myeloid leukemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastroenteropancreatic neuroendocrine tumor disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Transitional cell carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia klebsiella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Response (CR) Rate for UGN-102 Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.1', 'groupId': 'OG000', 'lowerLimit': '52.0', 'upperLimit': '76.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months after the first instillation of UGN-102', 'description': 'To evaluate the tumor ablative effect of UGN-102 in patients with LG NMIBC. CR rate was defined as the percentage of patients with no detectable disease (NDD) as determined by cystoscopy, for cause biopsy, and urine cytology.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) analysis set (all patients who were enrolled into the study and received at least one instillation of UGN-102)'}, {'type': 'SECONDARY', 'title': 'Durable Complete Response (DCR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'classes': [{'title': '6 months (3 months after CR at the 3-month Visit)', 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '83.5', 'upperLimit': '99.4'}]}]}, {'title': '9 months (6 months after CR at the 3-month Visit)', 'categories': [{'measurements': [{'value': '73.2', 'groupId': 'OG000', 'lowerLimit': '57.1', 'upperLimit': '85.8'}]}]}, {'title': '12 months (9 months after CR at the 3-month Visit)', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000', 'lowerLimit': '44.5', 'upperLimit': '75.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6, 9, and 12 months after the first instillation of UGN-102', 'description': 'To evaluate the durability of response in patients with LG NMIBC who achieve CR. DCR rate was defined as the percentage of patients who maintained CR at the respective time point.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3-month CR analysis set (patients who achieved CR at the 3-month Visit)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs), Study Drug or Procedure Related TEAEs, TEAEs by Maximum Severity, TEAEs Leading to Treatment Discontinuation, and Serious TEAEs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Any study drug or procedure related TEAEs', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Maximum severity Grade 1', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Maximum severity Grade 2', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Maximum severity Grade 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Maximum severity Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Maximum severity Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Any TEAEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Any serious TEAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'The number of patients with each type of event will be summarized. Adverse event severity was graded according to Common Terminology Criteria for Adverse Events version 5.0 as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant), Grade 4 (life-threatening), Grade 5 (fatal).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set (all patients who were enrolled into the study and received at least one instillation of UGN-102), which is identical to the safety analysis set for this study'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'classes': [{'title': 'Any PCS chemistry value', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Any PCS hematology value', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'The number of patients who met PCS criteria for chemistry or hematology parameters post-baseline will be summarized', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set (all patients who were enrolled into the study and received at least one instillation of UGN-102), which is identical to the safety analysis set for this study'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-baseline PCS Vital Signs Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'The number of patients who met PCS criteria for vital signs parameters post-baseline will be summarized', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set (all patients who were enrolled into the study and received at least one instillation of UGN-102), which is identical to the safety analysis set for this study'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-baseline Clinically Significant (CS) Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'The number of patients with abnormal, CS physical examination findings post-baseline will be summarized', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set (all patients who were enrolled into the study and received at least one instillation of UGN-102), which is identical to the safety analysis set for this study'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-baseline CS Urology-oriented Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'The number of patients with abnormal, CS urology-oriented physical examination findings post-baseline will be summarized', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set (all patients who were enrolled into the study and received at least one instillation of UGN-102), which is identical to the safety analysis set for this study'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mitomycin Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'classes': [{'title': 'Pre-instillation', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '0.5 hours post-instillation', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.57', 'groupId': 'OG000'}]}]}, {'title': '1 hour post-instillation', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.42', 'groupId': 'OG000'}]}]}, {'title': '2 hours post-instillation', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.17', 'groupId': 'OG000'}]}]}, {'title': '3 hours post-instillation', 'categories': [{'measurements': [{'value': '1.88', 'spread': '3.13', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-instillation', 'categories': [{'measurements': [{'value': '1.93', 'spread': '3.49', 'groupId': 'OG000'}]}]}, {'title': '5 hours post-instillation', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.61', 'groupId': 'OG000'}]}]}, {'title': '6 hours post-instillation', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102', 'description': 'Mitomycin plasma concentrations were assessed in a subset of 6 patients treated with UGN-102', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set (all patients who consented to provide blood samples for PK analysis and had at least 1 plasma sample for evaluation of PK properties of mitomycin following an initial instillation of UGN-102)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mitomycin Area Under the Plasma Concentration-time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.69', 'spread': '7.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-instillation) to 6 hours after the first instillation of UGN-102', 'description': 'Mitomycin AUC was assessed in a subset of 6 patients treated with UGN-102', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set (all patients who consented to provide blood samples for PK analysis and had at least 1 plasma sample for evaluation of PK properties of mitomycin following an initial instillation of UGN-102)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mitomycin Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.27', 'spread': '3.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102', 'description': 'Mitomycin Cmax was assessed in a subset of 6 patients treated with UGN-102', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set (all patients who consented to provide blood samples for PK analysis and had at least 1 plasma sample for evaluation of PK properties of mitomycin following an initial instillation of UGN-102)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Refused to come in for the final 12-month assessment due to COVID-19', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'UGN-102', 'description': '6 once-weekly intravesical instillations of UGN-102.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '96'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Size', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=3 centimeters', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': '>3 centimeters', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data on tumor size were missing for 2 patients.'}, {'title': 'Tumor Number', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Single', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Multiple', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data on tumor number were missing for 2 patients.'}, {'title': 'Visual Appearance of Lesions', 'classes': [{'title': 'Papillary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}, {'title': 'Flat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients may be included in more than one category of visual appearance of lesions.', 'unitOfMeasure': 'participants'}, {'title': 'Tumor Staging', 'classes': [{'title': 'Noninvasive papillary carcinoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients may be included in more than one category of tumor staging.', 'unitOfMeasure': 'participants'}, {'title': 'Tumor Grading', 'classes': [{'title': 'Papillary urothelial carcinoma, low grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}, {'title': 'Papillary urothelial neoplasm of low malignant potential', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients may be included in more than one category of tumor grading.', 'unitOfMeasure': 'participants'}, {'title': 'Any Previous Low Grade Non-muscle-invasive Bladder Cancer (LG NMIBC) Episode', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous LG NMIBC Episode Within 1 Year of Current Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Previous LG NMIBC Episodes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '1-2', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>2', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Prior Transurethral Resection of Bladder Tumors (TURBT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '13'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'TURBTs', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data on prior TURBT were summarized for patients with a previous LG NMIBC episode.'}, {'title': 'Patients With Number of Prior TURBT', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=3', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data on prior TURBT were summarized for patients with a previous LG NMIBC episode.'}, {'title': 'Days Since Last TURBT at Time of Day 1', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=365', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '>365', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Days since last TURBT were summarized for patients with a previous LG NMIBC episode and a prior TURBT.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-15', 'size': 964052, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-24T12:35', 'hasProtocol': True}, {'date': '2020-07-24', 'size': 694163, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-24T12:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'dispFirstSubmitDate': '2020-12-09', 'completionDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2018-05-08', 'dispFirstSubmitQcDate': '2020-12-09', 'resultsFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2018-06-03', 'dispFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-29', 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mitomycin Plasma Concentrations', 'timeFrame': '0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102', 'description': 'Mitomycin plasma concentrations were assessed in a subset of 6 patients treated with UGN-102'}, {'measure': 'Mitomycin Area Under the Plasma Concentration-time Curve (AUC)', 'timeFrame': '0 (pre-instillation) to 6 hours after the first instillation of UGN-102', 'description': 'Mitomycin AUC was assessed in a subset of 6 patients treated with UGN-102'}, {'measure': 'Mitomycin Maximum Plasma Concentration (Cmax)', 'timeFrame': '0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102', 'description': 'Mitomycin Cmax was assessed in a subset of 6 patients treated with UGN-102'}], 'primaryOutcomes': [{'measure': 'Complete Response (CR) Rate for UGN-102 Treatment', 'timeFrame': '3 months after the first instillation of UGN-102', 'description': 'To evaluate the tumor ablative effect of UGN-102 in patients with LG NMIBC. CR rate was defined as the percentage of patients with no detectable disease (NDD) as determined by cystoscopy, for cause biopsy, and urine cytology.'}], 'secondaryOutcomes': [{'measure': 'Durable Complete Response (DCR) Rate', 'timeFrame': '6, 9, and 12 months after the first instillation of UGN-102', 'description': 'To evaluate the durability of response in patients with LG NMIBC who achieve CR. DCR rate was defined as the percentage of patients who maintained CR at the respective time point.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs), Study Drug or Procedure Related TEAEs, TEAEs by Maximum Severity, TEAEs Leading to Treatment Discontinuation, and Serious TEAEs.', 'timeFrame': 'Up to 12 months', 'description': 'The number of patients with each type of event will be summarized. Adverse event severity was graded according to Common Terminology Criteria for Adverse Events version 5.0 as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant), Grade 4 (life-threatening), Grade 5 (fatal).'}, {'measure': 'Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory Values', 'timeFrame': 'Up to 12 months', 'description': 'The number of patients who met PCS criteria for chemistry or hematology parameters post-baseline will be summarized'}, {'measure': 'Number of Participants With Post-baseline PCS Vital Signs Values', 'timeFrame': 'Up to 12 months', 'description': 'The number of patients who met PCS criteria for vital signs parameters post-baseline will be summarized'}, {'measure': 'Number of Participants With Post-baseline Clinically Significant (CS) Physical Examination Findings', 'timeFrame': 'Up to 12 months', 'description': 'The number of patients with abnormal, CS physical examination findings post-baseline will be summarized'}, {'measure': 'Number of Participants With Post-baseline CS Urology-oriented Physical Examination Findings', 'timeFrame': 'Up to 12 months', 'description': 'The number of patients with abnormal, CS urology-oriented physical examination findings post-baseline will be summarized'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-muscle invasive bladder cancer', 'Low grade non-muscle invasive bladder cancer', 'Intermediate risk non-muscle invasive bladder cancer', 'NMIBC', 'UGN-102', 'Mitomycin'], 'conditions': ['Bladder Cancer', 'Urothelial Carcinoma', 'Urothelial Carcinoma Bladder']}, 'referencesModule': {'references': [{'pmid': '34433303', 'type': 'RESULT', 'citation': "Chevli KK, Shore ND, Trainer A, Smith AB, Saltzstein D, Ehrlich Y, Raman JD, Friedman B, D'Anna R, Morris D, Hu B, Tyson M, Sankin A, Kates M, Linehan J, Scherr D, Kester S, Verni M, Chamie K, Karsh L, Cinman A, Meads A, Lahiri S, Malinowski M, Gabai N, Raju S, Schoenberg M, Seltzer E, Huang WC. Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial. J Urol. 2022 Jan;207(1):61-69. doi: 10.1097/JU.0000000000002186. Epub 2021 Aug 26."}, {'pmid': '41074972', 'type': 'DERIVED', 'citation': 'Prasad SM, Louie MJ, Burger B, Tsurutis V, Ugwuoke N, Strauss-Ayali D. Pharmacokinetics of UGN-102, an investigational mitomycin-containing reverse thermal gel for the treatment of non-muscle invasive bladder cancer. Cancer Chemother Pharmacol. 2025 Oct 11;95(1):100. doi: 10.1007/s00280-025-04821-5.'}, {'pmid': '35640276', 'type': 'DERIVED', 'citation': 'Stover AM, Basak R, Mueller D, Lipman R, Teal R, Hilton A, Giannone K, Waheed M, Smith AB. Minimal Patient-Reported Side Effects for a Chemoablative Gel (UGN-102) Used as Frontline Treatment in Adults with Nonmuscle-Invasive Bladder Cancer. J Urol. 2022 Sep;208(3):580-588. doi: 10.1097/JU.0000000000002747. Epub 2022 May 31.'}]}, 'descriptionModule': {'briefSummary': 'This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).', 'detailedDescription': 'Eligible patients were treated with 6 once-weekly intravesical instillations of UGN-102.\n\nThe ablative effect of UGN-102 was evaluated at the 3-month Visit, which occurred 5 weeks ± 1 week after the last weekly instillation (3 months after initiation of study drug). Response was determined based on visual evaluation by cystoscopy (appearance, number, and size of the lesions) and, if there were remaining lesions, by histopathology of the remaining lesions. Complete response (CR) was defined as having no detectable disease (NDD) and was assessed visually during cystoscopy and also by urine cytology. In the event that the investigator was not sure, and there was suspect tissue, a small biopsy was taken from the suspect tissue to confirm CR in addition to cystoscopy and urine cytology.\n\nPatients who achieved a CR continued to have monthly telephone contacts to document any adverse events (AEs) and changes in concomitant medications and were assessed at 6, 9, and 12 months after the first instillation of UGN-102 for evidence of disease recurrence. Patients who had a non-complete response (non-CR) discontinued the study and continued with standard of care according to their treating physician.\n\nSafety was determined based on a review of AEs, laboratory assessments, and physical examination findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to sign an informed consent and comply with the protocol.\n2. Has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 6 weeks of screening.\n3. Is at intermediate risk of recurrence, defined as having 1 or 2 of the following:\n\n * Presence of multiple tumors;\n * Solitary tumor \\> 3 cm;\n * Recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis).\n4. Has negative voiding cytology for high grade (HG) disease at or within 6 weeks of enrollment.\n5. Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the participant is female or the female partner of a male participant and is of childbearing potential (defined as premenopausal women who have not been sterilized).\n6. Has adequate organ and bone marrow function as determined by routine laboratory tests as below:\n\n * Leukocytes ≥ 3,000 per μL;\n * Absolute neutrophil count ≥ 1,500 per μL;\n * Platelets ≥ 100,000 per μL;\n * Hemoglobin ≥ 9.0 g/dL;\n * Total bilirubin ≤ 1.5 x upper limit of normal (ULN);\n * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;\n * Alkaline phosphatase ≤ 2.5 × ULN;\n * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.\n7. Has no evidence of active urinary tract infection (UTI) at Screening and Baseline visits.\n\n * In the case of symptomatic UTI, the patient will be treated with a full course of antibiotics, and study drug will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of study drug is left to the discretion of the Principal Investigator (PI).\n\nExclusion Criteria:\n\n1. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment.\n2. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 2 years.\n3. History of HG papillary UC in the past 2 years.\n4. Known allergy or sensitivity to mitomycin.\n5. Clinically significant urethral stricture that would preclude passage of a urethral catheter.\n6. History of pelvic radiotherapy.\n7. History of:\n\n * Neurogenic bladder;\n * Active urinary retention;\n * Any other condition that would prohibit normal voiding.\n8. Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract urothelial carcinoma (UTUC).\n9. Has participated in a study with an investigational agent or device within 30 days of enrollment.\n10. History of prior treatment with an intravesical chemotherapeutic agent with the exception of a single dose of chemotherapy immediately after any previous transurethral resection of bladder tumors (TURBT).\n11. 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.'}, 'identificationModule': {'nctId': 'NCT03558503', 'acronym': 'OPTIMA II', 'briefTitle': 'A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'UroGen Pharma Ltd.'}, 'officialTitle': 'A Phase 2b, Single-Arm, Multicenter Trial 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 of Recurrence', 'orgStudyIdInfo': {'id': 'TC-BC-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UGN-102', 'description': 'Patients were treated with 6 once-weekly intravesical instillations of UGN-102.', 'interventionNames': ['Drug: UGN-102']}], 'interventions': [{'name': 'UGN-102', 'type': 'DRUG', 'otherNames': ['UGN-102 (mitomycin) for intravesical solution'], 'description': '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.\n\nThe UGN-102 admixture for intravesical instillations contains 75 mg mitomycin in 56 mL admixture (1.33 mg mitomycin per 1 mL).', 'armGroupLabels': ['UGN-102']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Urology', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Providence Medical Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33060', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Center of Florida', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Adult & Pediatric Urology, PC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89144', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Urology Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Medical Research', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center (Albert Einstein)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14225', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Western New York Urology Associates', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27572', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey State College', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Urologic Research Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '37209', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Urology Associates, PC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78233', 'city': 'Fredericksburg', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology San Antonio', 'geoPoint': {'lat': 30.2752, 'lon': -98.87198}}, {'zip': '3436212', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '49372', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Elyse Seltzer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UroGen Pharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UroGen Pharma Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}