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

NCT ID: NCT03058406

Last Updated: 2020-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

256 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2018-11-04

Brief Summary

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

Detailed Description

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Conditions

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Sarcoma, Soft Tissue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Eribulin mesylate

Eribulin mesylate

Intervention Type 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.

Interventions

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Eribulin 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.

Intervention Type DRUG

Other Intervention Names

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Halaven Injection E7389

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Osaka, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 35546669 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31365116 (View on PubMed)

Other Identifiers

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E7389-M081-503

Identifier Type: -

Identifier Source: org_study_id

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