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Trial record 99 of 157 for:    eribulin

Halaven Post-Marketing Surveillance (PMS)

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: NCT02441764
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

Brief Summary:
This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.

Condition or disease
Breast Cancer

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Study Type : Observational
Actual Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Halaven Injection in Korean Patients
Actual Study Start Date : March 2013
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Halaven
Participants who are prescribed with Halaven per approved prescribing information of Halaven.



Primary Outcome Measures :
  1. Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. Tumor response to Halaven treatment [ Time Frame: Up to 12 weeks ]


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 who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study.
Criteria

Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study. This study will be conducted as complete surveillance method; participants who meet the inclusion/exclusion criteria and administrate Halaven for the first time after conclusion of agreement will be enrolled after consent.

Inclusion Criteria:

Participants who meet all of the following criteria will be eligible for inclusion in the study:

  1. Participants with following indication: Participants with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens which should have included an anthracycline and a taxane.
  2. Participants who have verbal or written consent for use of personal and medical information.

Investigators will refer to indications regarding inclusion criteria.

Exclusion Criteria:

  1. Hypersensitivity to the active substance or to any of the excipients
  2. Breast feeding
  3. Pregnancy

Investigators will refer to indications and contraindications regarding exclusion criteria.


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): NCT02441764


Locations
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Korea, Republic of
Busan, Korea, Republic of
Chuncheongnam-do, Korea, Republic of
Chungcheongbuk-do, Korea, Republic of
Chungcheongnam-do, Korea, Republic of
Daegu, Korea, Republic of
Gwangju, Korea, Republic of
Gyeonggi-do, Korea, Republic of
Gyeongsanbuk-do, Korea, Republic of
Gyeongsannam-do, Korea, Republic of
Jeollabuk-do, Korea, Republic of
Jeollanam-do, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.

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Responsible Party: Eisai Korea Inc.
ClinicalTrials.gov Identifier: NCT02441764     History of Changes
Other Study ID Numbers: EKI-PMS-1201
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: June 2018

Keywords provided by Eisai Inc. ( Eisai Korea Inc. ):
Halaven
Eribulin Mesylate
locally advanced or metastatic breast cancer