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

StatusActive, Not Recruiting
PhasePhase 1/2
Started2006-10-23
View on ClinicalTrials.gov ↗
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.

Amendment history 4 changes detected by DataLookout

2026-09-10
Primary endpoint(s) modified
WasMTD and RP2D of eribulin mesylate for patients who have not received a tubulin-inhibitor for the recurrent/advanced disease (Phase I), Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of eribulin mesylate for patients who have received a tubulin-inhibitor for the recurrent/advanced disease (Phase I), Overall response rate
NowMTD of Eribulin Mesylate for Patients Who Have Not Received a Tubulin-inhibitor for the Recurrent/Advanced Disease (Phase I), Maximum Tolerated Dose (MTD) of Eribulin Mesylate for Patients Who Have Received a Tubulin-inhibitor for the Recurrent/Advanced Disease (Phase I), Number of Subjects With Overall Response
2026-09-10
Enrollment increased: 132 → 171 participants
2026-09-10
Completion pushed: 2026-07-09 → 2027-07-09
2026-09-10
Results posted: 2026-09-09
Trial Details
NCT Number NCT00365157
Lead Sponsor National Cancer Institute (NCI)
Conditions Advanced Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Recurrent Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7, Unresectable Urothelial Carcinoma
Enrollment 171 participants
Start Date 2006-10-23
Primary Completion 2025-07-09 (estimated)
Study Completion 2027-07-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-09