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NCT05055050 · ClinicalTrials.gov registry record · Phase 1
A Window of Opportunity Phase I Study of UGN-201 in Patients With Bladder Cancer Undergoing Radical Cystectomy Protocol #: 2021-0630
A Phase 1 study of Bladder Cancer and Bladder, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05055050 is a Phase 1 study of Bladder Cancer and Bladder that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 10 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05055050, a Phase 1 study of Bladder Cancer and Bladder, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
he primary objective is to characterize the safety profile of UGN-201 in patients with urothelial carcinoma undergoing radical cystectomy. Corresponding primary endpoint: Toxicity of concern (TOX) will be monitored until 30 days after surgery or until the patient meets the surgery prevention or delay TOX definition below, whichever comes first. A patient will be considered to have a TOX if any of the following apply: * Any 30-day grade 3 or higher surgical complication at least possibly related to UGI-201 * Any toxicity at least possibly related to the treatment that prevents surgery or delays it more than 12 weeks from date of cystectomy decision with MDACC Urologist. Missing/delayed surgery due to progression or withdrawal not related to toxicity will not count as a TOX event. Rapid progression is not seen with UGN-201. For such a patient, TOX monitoring will follow for 30 days after the administered dose of UGN-201. * Death between the start of study and the 30-day post-surgical assessment will count if it is toxic death at least possibly related to the UGN-201 or surgery. Deaths clearly unrelated to treatment will not count as an event. Adverse events will be recorded using CTCAE v5 and surgical complications will be recorded using Clavien-Dindo classification. Exploratory objectives are: * To evaluate the efficacy of UGN-201 by pathologic T0 and ≤ pT1 rate (pathologic down-staging) after neoadjuvant treatment with UGN-201, in patients with NMBIC and MIBC undergoing radical cystectomy, respectively. * To assess the immunological/biomarker changes in tumor tissues, peripheral blood, and urine in response to UGN-201 treatment in patients with bladder cancer undergoing radical cystectomy and to explore any potential association between these biomarker measures and antitumor activity. Patients with MIBC will be defined as having a response if their pathologic stage is pT1 stage or less. Patients with NMIBC will be defined as having a response if their patholog
Conditions Studied
Interventions
- DRUG UGN-201
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05055050
The ClinicalTrials.gov registry entry for NCT05055050 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which UGN-201 is the first listed.
NCT05055050 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05055050 about?
NCT05055050 is a clinical study titled "A Window of Opportunity Phase I Study of UGN-201 in Patients With Bladder Cancer Undergoing Radical Cystectomy Protocol #: 2021-0630". he primary objective is to characterize the safety profile of UGN-201 in patients with urothelial carcinoma undergoing radical cystectomy. Corresponding primary endpoint: Toxicity of concern (TOX) will be monitored until 30 days after surgery or until the patient meets the surgery prevention or del...
What is the current status of trial NCT05055050?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2022-01-24. Estimated completion is 2026-08-31.
What conditions does trial NCT05055050 study?
This clinical trial studies the following conditions: Bladder Cancer, Bladder.
What interventions are being tested in trial NCT05055050?
The interventions under investigation include: UGN-201 (DRUG).
Who is sponsoring clinical trial NCT05055050?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05055050 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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