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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
13,920 Previous Clinical Trials
41,016,802 Total Patients Enrolled
David I QuinnPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
1 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor expects me to live more than 6 months.I am HIV-negative or if positive, not on antiretroviral therapy and have a CD4+ count > 500/mm3.My bladder cancer cannot be removed with surgery and has spread.My cancer is confirmed to be urothelial carcinoma.I am not pregnant or breastfeeding if I am to be treated with E7389.I have previously been treated with eribulin.I've had platinum-based chemo for my advanced or recurrent cancer and also had a tubulin inhibitor.I have a tumor that can be measured with a scan.My medication use will be reviewed to ensure it doesn't interfere with the trial drug.I am a woman willing to join drug level studies, with or without previous treatments.I agree to use birth control during the study due to unknown effects on fetuses.I have had up to two chemotherapy treatments for my advanced disease.My kidney function is either normal or moderately to severely reduced.I do not have untreated or worsening brain metastasis.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I can take care of myself but may not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (eribulin mesylate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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