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

Completed

• Conditions: Sarcoma, Soft Tissue
• Interventions: Drug: Eribulin mesylate

• Registration Number: NCT03058406
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-20
• Status Verified: 2018-08
• Primary Completion: 2018-11-04
• Study Completion: 2018-11-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eribulin mesylate	Eribulin mesylate	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Survival Rate at Year 2	up to 2 years