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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
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 3 of 3 changed
See other at-risk trials from National Cancer Institute (NCI)

Amendment history

The 50 most recent of 154 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Notable

    Primary endpoint(s) modified

    Results posted: 2026-09-09; Enrollment increased: 132 → 171 participants; Completion pushed from Jul 9, 2026 to Jul 9, 2027; and 1 more

    Show all 5 changes in this update
    • Notable Primary endpoint(s) modified
      Show what changed (3 entries, revised)
      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
    • Notable Results posted: 2026-09-09
    • Minor Enrollment increased: 132 → 171 participants
    • Minor Completion pushed from Jul 9, 2026 to Jul 9, 2027
    • Minor Secondary endpoints revised (4)
      Show what changed
      Progression-free survivalSurvival (Phase II) Progression-free survivalSurvival (Phase II) Overall survivalSurvival (Phase II) IncidenceNumber of adverseParticipants eventsWith Adverse Events (AE)

    Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv154

  2. Minor

    Primary completion date changed from estimate of Sep 1, 2025 to Jul 9, 2025

    Completion date: Sep 1, 2025 to Jul 9, 2026

    Study Status, Study Designv153

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v152

  4. Notable

    Primary and study completion dates: Aug 1, 2024 to Sep 1, 2025

    Study Statusv151

  5. Notable

    Primary and study completion dates: Dec 31, 2023 to Aug 1, 2024

    Study Statusv150

Show 45 earlier versions

  1. Minor

    2 amendments

    2 re-verifications since 2023-08-23, no change to tracked fields

    v148-v149

  2. Notable

    Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023

    Study Statusv147

  3. Minor

    3 amendments

    3 re-verifications since 2022-06-07, no change to tracked fields

    v144-v146

  4. Notable

    Primary completion date: Dec 31, 2021 to Dec 31, 2022

    Completion date: Dec 31, 2022

    Study Statusv143

  5. Minor

    Study sites revised (26)

    Show what changed: Study sites
    DuPageDuly MedicalHealth Groupand -Care Joliet

    Study Status, Contacts/Locationsv142

  6. Minor

    Study Status

    Re-verified, no change to tracked fields

    v141

  7. Minor

    Study sites revised (26)

    Show what changed: Study sites
    DuPage Medical Group - Joliet Oncology-Hematology Associates Limited

    Study Status, Contacts/Locationsv140

  8. Minor

    Eligibility criteria expanded, about 92 words

    Show what changed: Eligibility criteria
    [...] ollowing review of their case by the principal investigator WomenThe 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 adequa [...] udy 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 second [...] [...]

    Study Status, Eligibilityv139

  9. Notable

    Primary completion date: Jan 31, 2021 to Dec 31, 2021

    Study Statusv138

  10. Notable

    Primary endpoints revised (3)

    Primary completion date: Dec 31, 2020 to Jan 31, 2021; Secondary endpoints revised (4); Study description expanded, about 8 words

    Show what changed: Primary endpoints
    Overall response rate calculated as the ratio of the number of eligible patients who experienced a confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors version 1.1 (Phase II)
    Show what changed: Secondary endpoints
    Incidence of adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
    Show what changed: Study description
    PRIMARY OBJECTIVES: I. To establish whether E7389 (eribulin mesylate (E7389) can be given safely to patients with moderate and severe r [...] include paclitaxel, docetaxel and vinblastine). (Phase II) (per Amendment 6) VII. To determine the 6-month progression-free survival and [...] based therapy for recurrent or advanced disease. (Phase II) (per Amendment 6) VIII. To document the toxicity associated with the administr [...] a patients in the second line and later setting. (Phase II) (per Amendment 6) IX. To compare men and women with advanced bladder cancer tr [...] leucopenia, infection). (Enrollment to additional [...]

    Study Status, Oversight, Study Description, Conditions, Arms and Interventions, Outcome Measuresv137

  11. Minor

    3 amendments

    3 re-verifications since 2020-02-03, no change to tracked fields

    v134-v136

  12. Notable

    Primary completion date: Dec 31, 2019 to Dec 31, 2020

    Study Statusv133

  13. Minor

    3 amendments

    3 re-verifications since 2019-10-14, no change to tracked fields

    v130-v132

  14. Minor

    Study sites revised (26)

    Show what changed: Study sites
    Froedtert and the Medical College of Wisconsin

    Study Status, Contacts/Locationsv129

  15. Minor

    3 amendments

    3 re-verifications since 2019-02-05, no change to tracked fields

    v126-v128

  16. Notable

    Primary completion date: Dec 31, 2018 to Dec 31, 2019

    Study Statusv125

  17. Minor

    2 amendments

    2 re-verifications since 2018-10-22, no change to tracked fields

    v123-v124

  18. Minor

    Site details revised at 1 of 26 sites

    Study Status, Contacts/Locationsv122

  19. Minor

    Study Status

    Re-verified, no change to tracked fields

    v121

  20. Minor

    Secondary endpoints revised (4)

    Show what changed: Secondary endpoints
    Incidence of adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 45.0

    Study Status, Study Description, Outcome Measuresv120

  21. Minor

    Secondary endpoints reordered

    Study Status, Outcome Measuresv119

  22. Minor

    Study Status

    Re-verified, no change to tracked fields

    v118

  23. Notable

    Primary completion date: Dec 31, 2017 to Dec 31, 2018

    Study Statusv117

  24. Minor

    2 amendments

    2 re-verifications since 2017-11-20, no change to tracked fields

    v115-v116

  25. Notable

    Primary completion date: Aug 1, 2007 to Dec 31, 2017

    Study Status, Study Designv114

  26. Minor

    Primary completion date changed from estimate of Dec 31, 2017 to Aug 1, 2007

    Study Status, Study Designv113

  27. Minor

    3 amendments

    3 re-verifications since 2017-08-28, no change to tracked fields

    v110-v112

  28. Notable

    Primary endpoints revised (3)

    Secondary endpoints revised (4); Study description revised

    Show what changed: Primary endpoints
    [...] eived a tubulin-inhibitor for the recurrent/advanced disease, graded according to CTCAE v4.0 (Phase I) Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of eribulin mesylate f [...] eived a tubulin-inhibitor for the recurrent/advanced disease, graded according to CTCAE v4.0 (Phase I) Overall response rate calculated as the ratio of the number of eligible patients who experienced a confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors v1version 1.1 (Phase II)
    Show what changed: Secondary endpoints
    Incidence of adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4version 4.0
    Show what changed: Study description
    [...] two cohorts: tubulin-inhibitor treated or tubulin-inhibitor naïvenaive. (Tubulin inhibitors in common use for urothelial cancer in [...]

    Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measuresv109

  29. Minor

    3 amendments

    3 re-verifications since 2017-06-26, no change to tracked fields

    v106-v108

  30. Minor

    Primary completion date: Dec 2017 to Dec 31, 2017

    Start date: Oct 2006 to Oct 23, 2006

    Study Statusv105

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov