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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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22 December 2015 |
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Main ID: |
EUCTR2012-004463-41-ES |
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Date of registration:
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04/02/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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-
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Scientific title:
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- - MERIBEL |
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Date of first enrolment:
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03/03/2013 |
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Target sample size:
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60 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004463-41 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Portugal
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Spain
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Contacts
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Name:
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Medica Scientia Innovation Research
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Address:
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Simon Oller 2, 4rt 2a
08002
Barcelona
Spain |
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Telephone:
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003469534 87 12 |
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Email:
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joan.mercadal@medsir.org |
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Affiliation:
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Medica Scientia Innovation Research (MedSIR ARO) |
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Name:
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Medica Scientia Innovation Research
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Address:
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Simon Oller 2, 4rt 2a
08002
Barcelona
Spain |
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Telephone:
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003469534 87 12 |
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Email:
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joan.mercadal@medsir.org |
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Affiliation:
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Medica Scientia Innovation Research (MedSIR ARO) |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26
Exclusion criteria:
-
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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MedDRA version: 15.1
Level: LLT
Classification code 10027475
Term: Metastatic breast cancer
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Trade Name: Halaven
Product Name: HALAVEN
Product Code: -
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ERIBULIN
CAS Number: 253128-41-5
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: up to
Concentration number: 1.23-
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Primary Outcome(s)
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Primary end point(s): -
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Main Objective: -
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Timepoint(s) of evaluation of this end point: -
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Secondary Objective: -
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Secondary Outcome(s)
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Secondary end point(s): -
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Timepoint(s) of evaluation of this end point: -
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Secondary ID(s)
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OBU-SW-H-02
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Source(s) of Monetary Support
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Medica Scientia Innovation Research (MedSIR ARO)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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