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

Special Use Investigation of HALAVEN (HAL03T) - Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03058406

Acronym

HAL03T

Enrollment

256

Registered

2017-02-20

Start date

2016-03-01

Completion date

2018-11-04

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma, Soft Tissue

Keywords

Sarcoma, Soft Tissue, Halaven Injection, E7389

Brief summary

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

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- None

Design outcomes

Primary

Measure	Time frame
Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)	up to 2 years

Secondary

Measure	Time frame
Survival Rate at Year 2	up to 2 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026