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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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19 March 2012 |
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Main ID: |
EUCTR2004-003018-41-IT |
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Date of registration:
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01/02/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Open label, non-randomized, phase 2 Study investigating the effect of RAD001 monotherapy in patients with advanced NSCLC previously treated with either chemotherapy only or with chemotherapy and EGFR inhibitor s
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Scientific title:
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Open label, non-randomized, phase 2 Study investigating the effect of RAD001 monotherapy in patients with advanced NSCLC previously treated with either chemotherapy only or with chemotherapy and EGFR inhibitor s |
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Date of first enrolment:
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14/07/2005 |
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Target sample size:
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100 |
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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:2004-003018-41 |
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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: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Germany
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Italy
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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? 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
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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Treatment of advanced non-small cell lung cancer
MedDRA version: 9.1
Level: LLT
Classification code 10061873
Term: Non-small cell lung cancer
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Intervention(s)
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Product Name: everolimus
Product Code: RAD001C
Pharmaceutical Form: Tablet
CAS Number: 159351-69-6
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
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Primary Outcome(s)
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Primary end point(s):
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Secondary Objective:
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Main Objective:
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Secondary ID(s)
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2004-003018-41-DE
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CRAD001C2235
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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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URL:
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