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HAL03T: A Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas

Sponsor
Eisai Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03058406
Collaborator
(none)
256
Enrollment
2
Locations
32.1
Actual Duration (Months)
128
Patients Per Site
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to understand safety and efficacy in participants with soft tissue sarcomas.

Condition or Disease Intervention/Treatment Phase
  • Drug: Eribulin mesylate

Study Design

Study Type:
Observational
Actual Enrollment :
256 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Special Use Investigation of HALAVEN (HAL03T) - Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Nov 4, 2018
Actual Study Completion Date :
Nov 4, 2018

Arms and Interventions

Arm Intervention/Treatment
Eribulin mesylate

Drug: Eribulin mesylate
Participants will receive 1.4 milligrams per square meter (mg/m2) administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle and beyond.
Other Names:
  • Halaven Injection
  • E7389

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) [up to 2 years]

    Secondary Outcome Measures

    1. Survival Rate at Year 2 [up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osaka Japan
    2 Tokyo Japan

    Sponsors and Collaborators

    • Eisai Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eisai Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03058406
    Other Study ID Numbers:
    • E7389-M081-503
    First Posted:
    Feb 20, 2017
    Last Update Posted:
    Apr 6, 2020
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eisai Co., Ltd.
    Sarcoma, Soft Tissue
    Halaven Injection
    E7389
    Additional relevant MeSH terms:
    Sarcoma

    Study Results

    No Results Posted as of Apr 6, 2020