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

Overview

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

Full Title of Study: “Special Use Investigation of HALAVEN (HAL03T) – Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 4, 2018

Interventions

  • 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.

Arms, Groups and Cohorts

  • Eribulin mesylate

Clinical Trial Outcome Measures

Primary Measures

  • Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
    • Time Frame: up to 2 years

Secondary Measures

  • Survival Rate at Year 2
    • Time Frame: up to 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • Participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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