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
2
32.1
128
4

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.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 6, 2020