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NCT03058406 Clinical Trial

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

Sarcoma, Soft Tissue Clinical Trial

— HAL03T  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03058406
Other study ID # E7389-M081-503
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2016
Est. completion date November 4, 2018

Study information
Verified date August 2018
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 256
Est. completion date November 4, 2018
Est. primary completion date November 4, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) up to 2 years
Secondary Survival Rate at Year 2 up to 2 years
See also
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Completed NCT00061659 - Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Phase 2
Recruiting NCT03815474 - Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Soft Tissue Sarcoma Patients Phase 2
Recruiting NCT02812654 - Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment Phase 2
Completed NCT00204620 - Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS) Phase 2
Active, not recruiting NCT02415816 - Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas N/A
Withdrawn NCT02367651 - Study of Pazopanib Versus Placebo as Maintenance Therapy for Advanced Soft Tissue Sarcoma Phase 2