Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-03-12 @ 7:48 PM
Study NCT ID:
NCT03081858
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karl@lipaconcology.com', 'phone': '714-900-4412', 'title': 'Karl Bean', 'organization': 'LIPAC Oncology'}, 'certainAgreement': {'otherDetails': "At least 90 days before the proposed submission for publication/presentation of Study data or findings, the PI will provide the Sponsor with a manuscript for review. No release of confidential information without the Sponsor's written approval. Multi-center results to be published conjointly under Sponsor's direction, but if this final manuscript has not been published within 12 months after study end at all sites, the PI may publish results, subject to contract confidentiality.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.', 'description': 'The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.', 'eventGroups': [{'id': 'EG000', 'title': 'TSD-001 Administration Part 1, Cohort 1', 'description': "In part 1, these subjects were treated in a planned six-dose escalation of TSD-001 every 2 weeks via the intravesical route until DLT (establishing MTD) or until MDD was reached.\n\nTSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure).", 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TSD-001 Administration Part 1, Cohort 2', 'description': "In part 1, these subjects were treated in a planned six-dose escalation of TSD-001 every 2 weeks via the intravesical route until DLT (establishing MTD) or until MDD was reached.\n\nTSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure).", 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TSD-001 Administration Part 2, Cohort 1', 'description': "In part 2, cohort 1, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route for six doses.\n\nTSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).", 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'TSD-001 Administration Part 2, Cohort 2', 'description': "In part 2, cohort 2, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route for eight doses.\n\nTSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).", 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'TD-001 Part 3 (Long-term Surveillance)', 'description': 'All subjects in part 1 and part 2, were eligible for continued surveillance for safety event for up to 2 years after initial intravesical exposure to TSD-001. This observational study of safety (all subjects) and recurrence (Part 1 subjects only) followed standard of care cystoscopy bladder tumor follow-up every 3 months. During this time, only SAEs and those AEs related to SAEs were tracked and recorded.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Post procedural haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Anorgasmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Bladder discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Extraperitoneal Bladder Abscess', 'notes': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Abdominal Pain', 'notes': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}], 'seriousEvents': [{'term': 'acute pyelonephritis', 'notes': 'Initially presented with a urinary tract infection (UTI) from a multi-resistant E. Coli which failed antimicrobial therapy. The investigator concluded it was not related to study drug, but it was related to study procedure (i.e. catheterization).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}, {'term': 'Extraperitoneal Bladder abscess', 'notes': 'In Part 3, follow-up from part 1, patient with recurrent TaN0M0 bladder cancer (intermediate risk category) who was hospitalized for extraperitoneal bladder rupture and abscess due to complications of TURBT. Assessed as severe, unrelated to IP.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA,Version 20.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TSD-001 Administration Part 1, Cohort 1', 'description': "Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).\n\nTSD-001: Administered via intravesical instillation."}, {'id': 'OG001', 'title': 'TSD-001 Administration Part 1, Cohort 2', 'description': "Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).\n\nAs no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.\n\nTSD-001: Administered via intravesical instillation."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'MTD and/or MDD was not reached in dose escalation in Part 1, Cohort 1 patient treatments.', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Dose immediately preceding the dose at which DLT occurs or when a MDD is reached.', 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT/PK Population'}, {'type': 'PRIMARY', 'title': 'Part 2: Marker Lesion Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TSD-001 Administration Part 2, Cohort 1', 'description': "In part 2, cohort 1, the MDD of 360 mg was provided weekly via the intravesical route at weekly intervals for 6 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure). Marker lesion response was determined at 12 weeks (± 7 days) after Day 1."}, {'id': 'OG001', 'title': 'TSD Administration Part 2, Cohort 2', 'description': "In part 2, cohort 2, the MDD of 360 mg, established in part 1, was provided weekly via the intravesical route.\n\nThese subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 8 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). Marker lesion response was determined 15 weeks (± 7 days) after Day 1."}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Marker Lesion Response', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks (Cohort 1) or 15 weeks (Cohort 2)', 'description': 'Determine the marker lesion response rate at final assessment visit for subjects that received the MDD established in part 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) Population: The PP population will include subjects in the MITT population who have no major protocol violations.\n\nNote: Modified Intent-to-Treat (MITT) population includes all enrolled subjects who received at least one dose of study drug and have at least one post-baseline measurement of paclitaxel concentration.'}, {'type': 'SECONDARY', 'title': 'Part 1: Determine Paclitaxel Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TSD-001 Administration Part 1, Cohort 1: Day 1: 10 mg', 'description': "For these subjects, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG001', 'title': 'TSD-001 Administration Part 1, Cohort 1: Week 2: 25 mg', 'description': "For these subjects, the second dose was 25 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG002', 'title': 'TSD-001 Administration Part 1, Cohort 1: Week 4: 50 mg', 'description': "For these subjects, the third dose was 50 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG003', 'title': 'TSD-001 Administration Part 1, Cohort 1: Week 6: 75 mg', 'description': "For these subjects, the fourth dose was 75 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG004', 'title': 'TSD-001 Administration Part 1, Cohort 1: Week 8: 100 mg', 'description': "For these subjects, the fifth dose was 100 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG005', 'title': 'TSD-001 Administration Part 1, Cohort 1: Week 10: 150 mg', 'description': "For these subjects, the sixth dose was 150 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG006', 'title': 'TSD-001 Administration Part 1, Cohort 2: Day 1: 90 mg', 'description': "For these subjects, the initial dose was 90 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG007', 'title': 'TSD-001 Administration Part 1, Cohort 2: Week 2: 180 mg', 'description': "For these subjects, the second dose was 180 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG008', 'title': 'TSD-001 Administration Part 1, Cohort 2: Week 4: 270 mg', 'description': "For these subjects, the third dose was 270 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG009', 'title': 'TSD-001 Administration Part 1, Cohort 2: Week 6: 360 mg', 'description': "For these subjects, the fourth dose was 360 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG010', 'title': 'TSD-001 Administration Part 1, Cohort 2: Week 8: 450 mg', 'description': "For these subjects, the fifth dose was 450 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}, {'id': 'OG011', 'title': 'TSD-001 Administration Part 1, Cohort 2: Week 10: 540 mg', 'description': "For these subjects, the sixth dose was 540 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure."}], 'classes': [{'title': 'Predose Urine - Paclitaxel Concentration in Urine collected 15 minutes before', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}, {'value': '0', 'spread': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'spread': '0', 'groupId': 'OG006'}, {'value': '.8', 'spread': '1.4', 'groupId': 'OG007'}, {'value': '0', 'spread': '0', 'groupId': 'OG008'}, {'value': '0', 'spread': '0', 'groupId': 'OG009'}, {'value': '0', 'spread': '0', 'groupId': 'OG010'}, {'value': '0', 'spread': '0', 'groupId': 'OG011'}]}]}, {'title': 'Postdose Urine - Paclitaxel Concentration in Urine collected 2 hrs post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '19367', 'spread': '4341', 'groupId': 'OG000'}, {'value': '72933', 'spread': '50497', 'groupId': 'OG001'}, {'value': '189667', 'spread': '73433', 'groupId': 'OG002'}, {'value': '287333', 'spread': '134016', 'groupId': 'OG003'}, {'value': '436000', 'groupId': 'OG004'}, {'value': '446000', 'groupId': 'OG005'}, {'value': '241000', 'spread': '35539', 'groupId': 'OG006'}, {'value': '699000', 'spread': '272567', 'groupId': 'OG007'}, {'value': '686667', 'spread': '167861', 'groupId': 'OG008'}, {'value': '1161667', 'spread': '760795', 'groupId': 'OG009'}, {'value': '1800000', 'spread': '606300', 'groupId': 'OG010'}, {'value': '1886333', 'spread': '1317354', 'groupId': 'OG011'}]}]}, {'title': 'Predose Plasma - Paclitaxel Concentration in Plasma collected 15 minutes before', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'spread': '0', 'groupId': 'OG006'}, {'value': '0', 'spread': '0', 'groupId': 'OG007'}, {'value': '0', 'spread': '0', 'groupId': 'OG008'}, {'value': '0', 'spread': '0', 'groupId': 'OG009'}, {'value': '0', 'spread': '0', 'groupId': 'OG010'}, {'value': '0', 'spread': '0', 'groupId': 'OG011'}]}]}, {'title': 'Postdose Plasma - Paclitaxel Concentration in Plasma collected 2 hrs post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'spread': '0', 'groupId': 'OG006'}, {'value': '0', 'spread': '0', 'groupId': 'OG007'}, {'value': '0', 'spread': '0', 'groupId': 'OG008'}, {'value': '0', 'spread': '0', 'groupId': 'OG009'}, {'value': '0', 'spread': '0', 'groupId': 'OG010'}, {'value': '0', 'spread': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'Determine the local (bladder urine) and systemic (peripheral blood) paclitaxel concentrations before and after intravesical exposure to TSD-001 at all doses. Blood and urine samples were collected 15 (± 15) minutes before and 2 hours (± 10 minutes) after each instillation. Results are presented for different dose levels administered during dose escalation. The remaining results are grouped by cohort.', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) Population: The PP population will include subjects in the MITT population who have no major protocol violations.\n\nNote: Modified Intent-to-Treat (MITT) population includes all enrolled subjects who received at least one dose of study drug and have at least one post-baseline measurement of paclitaxel concentration.'}, {'type': 'SECONDARY', 'title': 'Part 2: Determine Paclitaxel Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TSD-001 Administration Part 2, Cohort 1', 'description': "In part 2, cohort 1, the MDD of 360 mg was instilled intravesically. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure)."}, {'id': 'OG001', 'title': 'TSD-001 Administration Part 2, Cohort 2', 'description': "In part 2, cohort 2, the MDD of 360 mg was instilled intravesically. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure)."}], 'classes': [{'title': 'Predose', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Postdose', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2 (pre and post dose)', 'description': 'Determine the systemic (peripheral blood) paclitaxel concentrations 15 (± 15) minutes before, and 2 hours (± 10 minutes) after the third intravesical instillation (Week 2) of TSD-001.', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP): This population will include subjects in the MITT population who have no major protocol violations.\n\nNote: The Modified Intent to Treat (MITT) population includes enrolled subjects who received at least one dose of study drug and have at least one post-baseline measurement of paclitaxel concentration.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Part 3: Rates of Recurrence/Disease-Free Survival in Part 1 Subjects Only at 12 and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TSD-001 Administration Part 1, Cohort 1: Long-term Follow-up (Part 3)', 'description': 'Part 1 patients were followed for recurrence free survival (RFS) for up to 2 years after initial TURBT and intravesical exposure to TSD-001. The tracking and recording of RFS occurred in TD-001 part 3, the observational study of recurrence in these patients. Patients enrolled in part 3 underwent standard of care cystoscopy bladder tumor follow-up every 3 months.'}, {'id': 'OG001', 'title': 'TSD-001 Administration Part 1, Cohort 2: Long-term Follow-up (Part 3)', 'description': 'Part 1 patients were followed for recurrence free survival (RFS) for up to 2 years after initial TURBT and intravesical exposure to TSD-001. The tracking and recording of RFS occurred in TD-001 part 3, the observational study of recurrence in these patients. Patients enrolled in part 3 underwent standard of care cystoscopy bladder tumor follow-up every 3 months.'}], 'classes': [{'title': 'One Year', 'categories': [{'title': 'Disease-Free', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Recurrence Occurred', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Two Year', 'categories': [{'title': 'Disease-Free', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Recurrence Occurred', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Long-term follow-up to determine when histological tissue diagnosis evidence of recurrence occurs for subjects after complete TURBT and exposure to TSD-001 in part 1. Cystoscopic surveillance was performed every 3 months from the last endoscopic assessment in part 1 until 24 months (from initial TURBT and instillation). Part 2 subjects, different than part 1 subjects, were followed for marker lesion response and did not have standardized TURBT timing to use as a baseline and so are not included in these reported RFS rates.\n\nRecurrence-free survival is no histological evidence of transitional cell carcinoma (TCC) recurrence in the time outlined for the TCC risk level.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The MITT population will include all enrolled subjects who received at least one dose of study drug and had at least one post-baseline measurement of paclitaxel concentration.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TSD-001 Administration Part 1, Cohort 1', 'description': "Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).\n\nTSD-001: Administered via intravesical instillation."}, {'id': 'FG001', 'title': 'TSD-001 Administration Part 1, Cohort 2', 'description': "Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).\n\nAs no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.\n\nTSD-001: Administered via intravesical instillation."}, {'id': 'FG002', 'title': 'TSD-001 Administration Part 2, Cohort 1', 'description': "In part 2, cohort 1, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route.\n\nDuring part 2, cohort 1, 6 additional subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 6 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).\n\nTSD-001: Administered via intravesical instillation."}, {'id': 'FG003', 'title': 'TSD-001 Administration Part 2, Cohort 2', 'description': "In part 2, cohort 2, the dose was selected as the MDD, established in part 1, and provided weekly via the intravesical route.\n\nDuring part 2, cohort 2, 3 additional subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 8 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).\n\nTSD-001: Administered via intravesical instillation."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Sponsor Discontinuation - IP issue for investigation (Bacterial Endotoxin level)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'TSD-001 Administration Part 1, Cohort 1', 'description': "Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).\n\nTSD-001: Administered via intravesical instillation."}, {'id': 'BG001', 'title': 'TSD-001 Administration Part 1, Cohort 2', 'description': "Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).\n\nAs no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.\n\nTSD-001: Administered via intravesical instillation."}, {'id': 'BG002', 'title': 'TSD-001 Administration Part 2, Cohort 1', 'description': "In part 2, cohort 1, the MDD of 360 mg, established in part 1, was provided weekly via the intravesical route.\n\nDuring part 2, cohort 1, 6 additional subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 6 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).\n\nTSD-001: Administered via intravesical instillation."}, {'id': 'BG003', 'title': 'TSD Administration Part 2, Cohort 2', 'description': "In part 2, cohort 1, the MDD of 360 mg, established in part 1, was provided weekly via the intravesical route.\n\nDuring part 2, cohort 2, 3 additional subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 8 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).\n\nTSD-001: Administered via intravesical instillation."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.33', 'spread': '8.96', 'groupId': 'BG000'}, {'value': '71.67', 'spread': '5.51', 'groupId': 'BG001'}, {'value': '57.50', 'spread': '16.99', 'groupId': 'BG002'}, {'value': '64.33', 'spread': '17.79', 'groupId': 'BG003'}, {'value': '65.27', 'spread': '14.85', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White/ Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Asian/ Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White/ Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Non-Muscle Invasive Bladder Cancer Recurrent', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Tumor Locations', 'classes': [{'categories': [{'title': 'Solitary', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Multifocal', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Intravesical Therapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'European Association of Urology (EAU) Risk Stratification', 'classes': [{'categories': [{'title': 'Low Risk', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Intermediate Risk', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Low risk defined as: Primary, Solitary, low-grade (LG)/grade 1 (G1)\\<3cm, no carcinoma in situ (CIS)\n\nIntermediate risk defined as: All tumors not defined in the two adjacent categories\n\nHigh risk defined as any of the following:\n\n* T1 stage tumor\n* high-grade/grade 3 (HG/G3) tumor\n* CIS\n* Multiple, recurrent, and large (\\>3cm) Ta tumor/low-grade (grade 1/Grade 2) (Ta G1/G2) tumors (all conditions present)', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-04', 'size': 2124707, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-01T14:55', 'hasProtocol': True}, {'date': '2020-10-27', 'size': 19636608, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-01T14:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2017-03-10', 'resultsFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-28', 'studyFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Part 3: Rates of Recurrence/Disease-Free Survival in Part 1 Subjects Only at 12 and 24 Months', 'timeFrame': '2 years', 'description': 'Long-term follow-up to determine when histological tissue diagnosis evidence of recurrence occurs for subjects after complete TURBT and exposure to TSD-001 in part 1. Cystoscopic surveillance was performed every 3 months from the last endoscopic assessment in part 1 until 24 months (from initial TURBT and instillation). Part 2 subjects, different than part 1 subjects, were followed for marker lesion response and did not have standardized TURBT timing to use as a baseline and so are not included in these reported RFS rates.\n\nRecurrence-free survival is no histological evidence of transitional cell carcinoma (TCC) recurrence in the time outlined for the TCC risk level.'}], 'primaryOutcomes': [{'measure': 'Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD)', 'timeFrame': '12 weeks', 'description': 'Dose immediately preceding the dose at which DLT occurs or when a MDD is reached.'}, {'measure': 'Part 2: Marker Lesion Response Rate', 'timeFrame': '12 weeks (Cohort 1) or 15 weeks (Cohort 2)', 'description': 'Determine the marker lesion response rate at final assessment visit for subjects that received the MDD established in part 1.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Determine Paclitaxel Concentrations', 'timeFrame': '10 weeks', 'description': 'Determine the local (bladder urine) and systemic (peripheral blood) paclitaxel concentrations before and after intravesical exposure to TSD-001 at all doses. Blood and urine samples were collected 15 (± 15) minutes before and 2 hours (± 10 minutes) after each instillation. Results are presented for different dose levels administered during dose escalation. The remaining results are grouped by cohort.'}, {'measure': 'Part 2: Determine Paclitaxel Concentrations', 'timeFrame': 'Week 2 (pre and post dose)', 'description': 'Determine the systemic (peripheral blood) paclitaxel concentrations 15 (± 15) minutes before, and 2 hours (± 10 minutes) after the third intravesical instillation (Week 2) of TSD-001.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NMIBC', 'Paclitaxel', 'Antineoplastic Agents', 'Bladder Cancer'], 'conditions': ['Bladder Cancer Cell Transitional', 'Non-Muscle Invasive Bladder Cancer', 'Bladder Cancer', 'Urinary Bladder', 'Transitional Cell Carcinoma of the Bladder', 'Urinary Bladder Neoplasms', 'Urologic Neoplasms', 'Urogenital Neoplasms', 'Urinary Bladder Diseases', 'Urologic Diseases']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder.\n\nPart 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established).\n\nPart 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta (uni-or multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest nontoxic dose (i.e., MTD) established in part 1 of the study. May meet definition of low grade without histological tissue diagnosis if on cystoscopic assessment they have a solitary papillary tumor.\n\nPart 3 of the study will continue to track subjects enrolled in Parts 1 and 2 to determine rates of disease-free survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a diagnosis of low grade (G1 or G2), uni- or multifocal papillary appearing bladder tumor, stage Ta.\n* For part 1, subject will have ≥ 1 and ≤ 5 tumors (prior to TURBT), none of which exceeds 3.0 cm in diameter; for part 2, patient will have ≥ 2 and ≤ 5 tumors (prior to TURBT), none of which exceeds 3.0 cm in diameter (resection loop \\~1 cm), OR, for part 2, subject meets this inclusion if on cystoscopic assessment they have a solitary papillary tumor (\\> 0.5 cm and ≤ 2.0 cm in diameter)..\n* Subject is surgical candidate for TURBT as part of normal NMIBC treatment plan. For part 1, successful completion of TURBT procedure. For part 2, successful completion of cystoscopic assessment/TURBT procedure with one marker lesion left intact; the marker lesion should be \\> 0.5 cm and \\< 2.0 cm in diameter.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Peripheral neuropathy grade 1 or less.\n* Adequate hematological, hepatic, and renal parameters; i.e., hemoglobin \\> 10 g/dL, creatinine \\< 3.5 mg/dL, bilirubin \\< 1.5 mg/dL , and aspartate aminotransferase, alanine aminotransferase \\< 50 U/L, and alkaline phosphatase \\< 130 U/L.\n* All sexually active subjects of reproductive potential are required to use or start using a reliable method of birth control at least 2 weeks prior to study enrollment, throughout the study, and for at least 3 months following completion of study therapy.\n* Females of childbearing potential must have a negative pregnancy test within 30 days prior to enrollment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.\n* For male subjects, the digital rectal examination must not be suspicious for carcinoma of the prostate.\n* Able to retain bladder instillations for up to 120 minutes (± 15 minutes).\n\nExclusion Criteria:\n\n* Has an active concurrent malignancy/life-threatening disease. If there is a history of prior malignancies/life-threatening diseases, the subject is to be disease free for at least 5 years. Subjects with other prior malignancies less than 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. Subjects will not be excluded for recurrent NMIBC, basal or squamous cell skin cancers, or noninvasive cancer of the cervix.\n* Has positive urine cytology for urothelial malignancy at screening.\n* Has an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the subject to receive protocol treatment.\n* Previous intravesical therapy within 6 months of study entry.\n* Prior radiation to the pelvis.\n* Participated in a previous clinical trial or used any investigational drugs, biologics, or devices within 90 days prior to study treatment or plans to use any of these during the course of the study.\n* Has had any previous exposure to paclitaxel or docetaxel in the last 5 years.\n* Has or has ever had: upper tract TCC; urethral tumor (prostatic urethra included); any invasive bladder tumor known to be other than tumor Ta, low-grade (G1-G2); any evidence of lymph node or distant metastasis; any bladder tumor with histology other than TCC; or carcinoma in situ (CIS).\n* Has a tumor in a bladder diverticulum\n* Concurrent treatment with any chemotherapeutic agent.\n* History of vesicoureteral reflux.\n* An indwelling ureteral stent.\n* Has received any pelvic radiotherapy (including external beam and/or brachytherapy.)\n* Has a bleeding disorder or a screening platelet count \\< 100×109/L.\n* Has an active diagnosis of interstitial cystitis.\n* For subjects with recurrent tumor, the subject had at least a 6-month cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination.\n* Presence of poorly controlled diabetes mellitus (glycated hemoglobin \\[HgbA1c\\] \\> 9.0%).'}, 'identificationModule': {'nctId': 'NCT03081858', 'briefTitle': 'Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lipac Oncology LLC'}, 'officialTitle': 'A Phase 1/2a Pilot Study of Intravesical TSD-001 for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'TD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TSD-001 Administration Part 1, Cohort 1', 'description': "Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose will be 10 mg in Sterile Water for Injection (SWFI). TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure). If Dose Limiting Toxicity(DLT) does not develop, intravesical instillation 14 days later will be titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI) until DLT (defined as any grade 3 or 4 toxicity or prolonged \\[greater than 14 days\\] grade 2 toxicity) is observed.", 'interventionNames': ['Drug: TSD-001']}, {'type': 'EXPERIMENTAL', 'label': 'TSD-001 Administration Part 1, Cohort 2', 'description': "Part 1, Cohort 1: For the next 3 subjects enrolled, the initial dose will be 90 mg in SWFI. TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure). If DLT does not develop, intravesical instillation 14 days later will be titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI) until DLT (defined as any grade 3 or 4 toxicity or prolonged \\[greater than 14 days\\] grade 2 toxicity) is observed.\n\nIf no DLT is observed in the first 6 subjects (cohorts 1 and 2) after titration up to 540 mg, then the maximum deliverable dose (MDD) will be defined and dose recommended for part 2 of the study.", 'interventionNames': ['Drug: TSD-001']}, {'type': 'EXPERIMENTAL', 'label': 'TSD-001 Administration Part 2', 'description': "In part 2, the dose will be selected as the MTD/MDD, established in part 1 and provided weekly via the intravesical route.\n\nDuring part 2, up to 10 additional subjects will receive intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MTD/MDD established in part 1 at weekly intervals for 6 consecutive weeks. TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure).", 'interventionNames': ['Drug: TSD-001']}], 'interventions': [{'name': 'TSD-001', 'type': 'DRUG', 'otherNames': ['Proliposomal Intravesical Paclitaxel'], 'description': 'Administered via intravesical instillation.', 'armGroupLabels': ['TSD-001 Administration Part 1, Cohort 1', 'TSD-001 Administration Part 1, Cohort 2', 'TSD-001 Administration Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Urological Associates of Southern Arizona, PC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Trovare Clinical Research', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tower Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '21076', 'city': 'Hanover', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Urology Associates', 'geoPoint': {'lat': 39.19289, 'lon': -76.72414}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Urologic Research Clinic', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}], 'overallOfficials': [{'name': 'Michael Oefelein, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lipac Oncology LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lipac Oncology LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'TesoRx Pharma, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}