← Back to Search

Microtubule Inhibitor

Eribulin Mesylate for Advanced Bladder Cancer

Phase 1 & 2
Waitlist Available
Led By David I Quinn
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Summary

This trial looks at the effect of eribulin mesylate on patients with cancer of the urothelium that has spread to nearby tissue or to other places in the body and kidney dysfunction.

Who is the study for?
This trial is for adults with advanced or metastatic urothelial cancer that can't be removed by surgery. They should have had some prior chemotherapy, but not the drug being tested. Participants need to have a life expectancy over 6 months, acceptable organ function, and agree to use contraception. Those with HIV on antiretroviral therapy, unstable brain metastasis, or severe illnesses are excluded.
What is being tested?
The trial is testing Eribulin Mesylate's effectiveness in patients with kidney dysfunction and locally advanced or metastatic urothelial cancer. It includes laboratory biomarker analysis and pharmacological studies to understand how the drug works when kidneys aren't functioning normally.
What are the potential side effects?
Eribulin Mesylate may cause side effects similar to other chemotherapy drugs such as fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk or bleeding problems. Kidney dysfunction might also affect how these side effects present.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MTD 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
Secondary study objectives
Incidence of adverse events
Overall survival (Phase II)
Progression-free survival (Phase II)
Other study objectives
Disease control rate (complete response [CR] + partial response [PR] + stable disease [SD])
Expression levels of the tubulin isotypes
Pharmacokinetic parameters for eribulin mesylate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (eribulin mesylate)Experimental Treatment3 Interventions
Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eribulin Mesylate
2014
Completed Phase 4
~3420

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,269 Total Patients Enrolled
David I QuinnPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
1 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

Eribulin Mesylate (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00365157 — Phase 1 & 2
Urothelial Carcinoma Research Study Groups: Treatment (eribulin mesylate)
Urothelial Carcinoma Clinical Trial 2023: Eribulin Mesylate Highlights & Side Effects. Trial Name: NCT00365157 — Phase 1 & 2
Eribulin Mesylate (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00365157 — Phase 1 & 2
~7 spots leftby Sep 2025