A Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas
Overview
The purpose of this study is to understand safety and efficacy in participants with soft tissue sarcomas.
Full Title of Study: “Special Use Investigation of HALAVEN (HAL03T) – Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: November 4, 2018
Interventions
- Drug: 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.
Arms, Groups and Cohorts
- Eribulin mesylate
Clinical Trial Outcome Measures
Primary Measures
- Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
- Time Frame: up to 2 years
Secondary Measures
- Survival Rate at Year 2
- Time Frame: up to 2 years
Participating in This Clinical Trial
Inclusion Criteria
- Participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice Exclusion Criteria:
- None
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Eisai Co., Ltd.
- Provider of Information About this Clinical Study
- Sponsor
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