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

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

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Key information

Conditions

Sarcoma, Soft Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

eribulin mesylate

Drug

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

Primary outcomes

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

Time frame: up to 2 years

Secondary outcomes

Survival Rate at Year 2

Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: HAL03T

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Feb 20, 2017
Registry last updated: Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed