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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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2 October 2017 |
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Main ID: |
EUCTR2011-002228-42-FR |
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Date of registration:
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29/08/2011 |
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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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N/A
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Scientific title:
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N/A - AFINF2 |
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Date of first enrolment:
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Target sample size:
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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:2011-002228-42 |
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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
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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: 14.0
Level: PT
Classification code 10029268
Term: Neurofibromatosis
System Organ Class: 10010331 - Congenital, familial and genetic disorders
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Trade Name: Afinitor
Product Name: Afinitor
Pharmaceutical Form: Tablet
INN or Proposed INN: Evérolimus
Other descriptive name: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
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Primary Outcome(s)
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Main Objective:
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Source(s) of Monetary Support
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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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