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A phase I/II study of E7389 halichondrin b analog (NSC # 707389) in metastatic urothelial tract cancer and renal insufficiency

NCT ID NCT00365157

NEW Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

171 people

The number who actually took part.

Started

Oct 2006

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have locally advanced or metastatic urothelial cancer that is not amenable to surgical treatment * Patients must have histologically or cytologically confirmed urothelial tract carcinoma * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan * All patients may have received up to two prior lines of chemotherapy for recurrent/advanced disease * Patients must have received at least one platinum-based chemotherapy for recurrent/advanced disease; recurrent disease is defined as having recurred after definitive therapy and advanced disease is defined as T4 and/or N2 and/or M1; in addition, for completion of Cohort #2, patients must also have received a tubulin inhibitor as part of their therapy for urothelial cancer; for purposes of this evaluation, treatment with chemotherapy regimens where carboplatin or similar is substituted for cisplatin or where a taxane is added or removed will be considered the same regimen; tubulin inhibitors in common use include paclitaxel, docetaxel, and vinblastine; the exception to this requirement applies to women * Women with and without prior therapy are also eligible; priority will be given to those who consent to participating in the pharmacokinetic studies * Life expectancy of greater than 6 months * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and Karnofsky \>= 60% * Absolute neutrophil count \>= 1,000/mcL * Platelets \>= 100,000/mcL * Hemoglobin \>= 9 g/dL * Total bilirubin =\< 1.5 institutional upper limit of normal (IULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X IULN * Patients must have either (a) normal kidney function (i.e. creatinine =\< 1.5 X upper limit of normal \[ULN\] OR calculated creatinine clearance \>= 60 mL/min by the modified Cockcroft and Gault Formula OR a creatinine clearance \>= 60 mL/min obtained from a 24-hour urine collection) or (b) moderate or severe renal dysfunction (i.e. creatinine clearance \< 60 mL/min and \>= 20 mL/min) * Patients with symptomatic uremia, uncontrolled edema or unstable serum electrolytes should not enter the trial until such time as they have been stabilized - such patients should be discussed with the principal investigator * Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of E7389 Halichondrin analog will be determined following review of their case by the principal investigator * The effects of E7389 Halichondrin analog on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because tubulin inhibitors are known to be teratogenic, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Patients must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients may not be receiving any other investigational agents * Patients with brain metastasis that are unstable (i.e. presenting with neurologic symptoms that progress or require increasing doses of steroids within a 4-week period) or are untreated (i.e. not radiated) should be excluded * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because E7389 Halichondrin analog is tubulin inhibitor agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7389 Halichondrin analog, breastfeeding should be discontinued if the mother is treated with E7389 * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with E7389 Halichondrin analog; HIV-positive patients with CD4+ =\< 500/mm3 are ineligible because they are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in this group of patients when indicated * Prior therapy with E7389 Halichondrin analog (eribulin)

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma stage IVb bladder cancer transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

Contacts and locations

Locations

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 62702, United States

  • City of Hope Antelope Valley

    Lancaster, California, 93534, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • City of Hope South Pasadena

    South Pasadena, California, 91030, United States

  • Community Howard Regional Health

    Kokomo, Indiana, 46904, United States

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156, United States

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526, United States

  • Duly Health and Care Joliet

    Joliet, Illinois, 60435, United States

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845, United States

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615, United States

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141, United States

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201, United States

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628, United States

  • Oncology Care Associates PLLC

    Saint Joseph, Michigan, 49085, United States

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702, United States

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232, United States

  • Veterans Administration Hospital - Martinez

    Martinez, California, 94553, United States

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

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