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NCT00365157 · ClinicalTrials.gov registry record · Phase 1

Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction

A Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
132
Enrollment target
20
Study locations

NCT00365157: Active Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

NCT00365157 is a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 132 participants, roughly in line with the 126-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target. The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00365157, a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
132 participants
Enrollment target
20
Study locations

Study Summary

This phase I/II trial studies the effect of eribulin mesylate and to see how well it works in treating patients with cancer of the urothelium that has spread to nearby tissue (locally advanced) or to other places in the body (metastatic)and kidney dysfunction. Drugs used in chemotherapy, such as eribulin mesylate, 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. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.

Primary Outcome

MTD and RP2D will be graded according to Common Terminology Criteria for Adverse (CTCAE) version 5.0.

Conditions Studied

Metastatic Urothelial Carcinoma Locally Advanced Urothelial Carcinoma Unresectable Urothelial Carcinoma Advanced Urothelial Carcinoma Stage IV Bladder Urothelial Carcinoma AJCC v7 Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Recurrent Urothelial Carcinoma

Interventions

  • OTHER Laboratory Biomarker Analysis
  • OTHER Pharmacological Study
  • DRUG Eribulin Mesylate

Study Locations (20)

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago
  • Decatur Memorial Hospital - Decatur
  • NorthShore University HealthSystem-Evanston Hospital - Evanston
  • Ingalls Memorial Hospital - Harvey
  • Duly Health and Care Joliet - Joliet
  • Loyola University Medical Center - Maywood
  • Illinois CancerCare-Peoria - Peoria
  • Central Illinois Hematology Oncology Center - Springfield
  • Southern Illinois University School of Medicine - Springfield

California

  • Tower Cancer Research Foundation - Beverly Hills
  • City of Hope Comprehensive Cancer Center - Duarte
  • City of Hope Antelope Valley - Lancaster
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • Contra Costa Regional Medical Center - Martinez
  • Veterans Administration Hospital - Martinez - Martinez
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • City of Hope South Pasadena - South Pasadena

Indiana

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview - Fort Wayne
  • Community Howard Regional Health - Kokomo
  • Northern Indiana Cancer Research Consortium - South Bend

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2006-10-23
Est. Completion 2026-07-09
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT00365157 still lists

NCT00365157 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 126-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target.

The record links to 7 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT00365157 names 20 study sites across 3 states, led by Illinois, California, Indiana.

Frequently Asked Questions

What is clinical trial NCT00365157 about?

NCT00365157 is a clinical study titled "Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction". This phase I/II trial studies the effect of eribulin mesylate and to see how well it works in treating patients with cancer of the urothelium that has spread to nearby tissue (locally advanced) or to other places in the body (metastatic)and kidney dysfunction. Drugs used in chemotherapy, such as eri...

What is the current status of trial NCT00365157?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2006-10-23. Estimated completion is 2026-07-09.

What conditions does trial NCT00365157 study?

This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Unresectable Urothelial Carcinoma, Advanced Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma AJCC v7.

What interventions are being tested in trial NCT00365157?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Eribulin Mesylate (DRUG).

Who is sponsoring clinical trial NCT00365157?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00365157 being conducted?

This trial has 20 study locations across California, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Urothelial Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00365157's enrollment target sits among peer trials

132 8th of 30 higher than 23 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00365157, the US trial registry maintained by the National Library of Medicine. NCT00365157 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.