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Trial record 2 of 237300 for:    ALL

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT03058406
First received: February 16, 2017
Last updated: NA
Last verified: February 2017
History: No changes posted
  Purpose
The purpose of this study is to understand safety and efficacy in participants with soft tissue sarcomas.

Condition Intervention
Sarcoma, Soft Tissue
Drug: Eribulin mesylate

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

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

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

Estimated Enrollment: 160
Actual Study Start Date: March 2016
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03058406

Contacts
Contact: Customer Joy Department. EJ 81-120-161-454

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

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03058406     History of Changes
Other Study ID Numbers: E7389-M081-503 
Study First Received: February 16, 2017
Last Updated: February 16, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eisai Inc.:
Sarcoma, Soft Tissue
Halaven Injection
E7389

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on February 20, 2017