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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 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.

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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.

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

FieldValue
Enrollment Target 184 participants
Start Date 2021-06-28
Est. Completion 2030-08-15
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT04579224

The ClinicalTrials.gov registry entry for NCT04579224 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 125-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (47% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.