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NCT04579224 · ClinicalTrials.gov registry record · Phase 3
Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
A Phase 3 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 184
- Enrollment target
- 20
- Study locations
NCT04579224: Active Phase 3 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
NCT04579224 is a Phase 3 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 184 participants, above the 125-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04579224, a Phase 3 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 184 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, paclitaxel, and sacituzumab govitecan work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Docetaxel
- PROCEDURE Bone Scan
- DRUG Eribulin Mesylate
Study Locations (20)
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Keck Medicine of USC Koreatown - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Fremont - Rideout Cancer Center - Marysville
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Keck Medical Center of USC Pasadena - Pasadena
- University of California Davis Comprehensive Cancer Center - Sacramento
- Pacific Central Coast Health Center-San Luis Obispo - San Luis Obispo
- Mission Hope Medical Oncology - Santa Maria - Santa Maria
Colorado
- UCHealth University of Colorado Hospital - Aurora
- Penrose-Saint Francis Healthcare - Colorado Springs
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2030-08-15 |
| Phase | Phase 3 |
What the registry record for NCT04579224 still lists
NCT04579224 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, above the 125-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (47% higher).
The record links to 5 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04579224 names 20 study sites across 4 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT04579224 about?
NCT04579224 is a clinical study titled "Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer". This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, p...
What is the current status of trial NCT04579224?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 184 participants. The study started on 2021-06-28. Estimated completion is 2030-08-15.
What conditions does trial NCT04579224 study?
This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Stage IV Bladder Cancer AJCC v8, Refractory Bladder Urothelial Carcinoma, Refractory Urothelial Carcinoma.
What interventions are being tested in trial NCT04579224?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Docetaxel (DRUG), Bone Scan (PROCEDURE), Eribulin Mesylate (DRUG).
Who is sponsoring clinical trial NCT04579224?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04579224 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04579224's enrollment target sits among peer trials
184 7th of 30 higher than 24 of 30 other Metastatic Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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