NCT03058406

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2018

Completed
Last Updated

April 6, 2020

Status Verified

August 1, 2018

Enrollment Period

2.7 years

First QC Date

February 16, 2017

Last Update Submit

April 3, 2020

Conditions

Sarcoma, Soft Tissue

Keywords

Sarcoma, Soft TissueHalaven InjectionE7389

Outcome Measures

Primary Outcomes (1)

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

    up to 2 years

Secondary Outcomes (1)

  • Survival Rate at Year 2

    up to 2 years

Study Arms (1)

Eribulin mesylate

Drug: Eribulin mesylate

Interventions

Eribulin mesylateDRUG

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
Eribulin mesylate

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (2)

  • 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.

    PMID: 35546669DERIVED

  • 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.

    PMID: 31365116DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 20, 2017

Study Start

March 1, 2016

Primary Completion

November 4, 2018

Study Completion

November 4, 2018

Last Updated

April 6, 2020

Record last verified: 2018-08

Locations

JP(2)