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CompletedNCT03058406HAL03TUpdated Apr 6, 2020

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

An observational study in Sarcoma, Soft Tissue, sponsored by Eisai Co., Ltd.. Completed at 2 sites in Japan. Per ClinicalTrials.gov, last updated 2020-04-06.

Sponsored by Eisai Co., Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
256
Sex
All
01

Study summary

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

02

Conditions studied

  • Sarcoma, Soft Tissue

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Keywords

  • Sarcoma, Soft Tissue
  • Halaven Injection
  • E7389
03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 256 is above the median of 121 across 238 observational studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
256 participants (actual)
Patient registry
No

Groups and cohorts

  • Eribulin mesylate

    Drug: Eribulin mesylate

Interventions

  • DrugEribulin 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.

    Also known as: Halaven Injection, E7389

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What researchers measure

Primary outcomes

  1. Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)

    Time frame: up to 2 years

Secondary outcomes

  1. Survival Rate at Year 2

    Time frame: up to 2 years

07

Study locations

2 sites
  • Osaka, Japan
  • Tokyo, Japan
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References and documents

Publications

  • Kawai A, Narahara H, Takahashi S, Nakamura T, Kobayashi H, Megumi Y, Matsuoka T, Kobayashi E. Safety and effectiveness of eribulin in Japanese patients with soft tissue sarcoma including rare subtypes: a post-marketing observational study. BMC Cancer. 2022 May 11;22(1):528. doi: 10.1186/s12885-022-09527-y. PubMed 35546669 ↗
  • Kobayashi E, Naito Y, Asano N, Maejima A, Endo M, Takahashi S, Megumi Y, Kawai A. Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes. Jpn J Clin Oncol. 2019 Oct 1;49(10):938-946. doi: 10.1093/jjco/hyz096. PubMed 31365116 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03058406
Lead sponsor
Eisai Co., Ltd.
Responsible party
Sponsor
First posted
Feb 20, 2017
Start date
Mar 1, 2016
Primary completion
Nov 4, 2018
Completion
Nov 4, 2018
Last update
Apr 6, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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