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A Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas (HAL03T)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03058406
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease Intervention/treatment
Sarcoma, Soft Tissue Drug: Eribulin mesylate

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Study Type : Observational
Actual Enrollment : 256 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Use Investigation of HALAVEN (HAL03T) - Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : November 4, 2018
Actual Study Completion Date : November 4, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Eribulin mesylate 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.
Other Names:
  • Halaven Injection
  • E7389




Primary Outcome Measures :
  1. Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. Survival Rate at Year 2 [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058406


Locations
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Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03058406     History of Changes
Other Study ID Numbers: E7389-M081-503
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Sarcoma, Soft Tissue
Halaven Injection
E7389
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms