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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01103089 |
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Date of registration:
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05/04/2010 |
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Primary sponsor: |
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Public title:
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Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)
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Scientific title:
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Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP) |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01103089 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Retrospective
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Countries of recruitment
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Netherlands
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participation in the gefitinib Expanded Access Program
- Patient still uses gefitinib in September 2009
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Small Cell Lung Cancer
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Primary Outcome(s)
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The following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC.
[Time Frame: Characteristics will be recorded once, retrospectively]
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Secondary Outcome(s)
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long-term safety in subjects; what real life data measures are being taken by lung physicians to counter side effects caused by long term gefitinib treatment; the number, reason, effect and description of interventions that have been taken
[Time Frame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)]
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long-term safety: Number, reason and effect of interruptions during gefitinib use to determine side effects typical for the long-term treatment with gefitinib
[Time Frame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)]
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To assess the long-term safety in subjects treated with gefitinib by collecting information on: All adverse events that have lead to an interruption/reduction of gefitinib or another intervention
[Time Frame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)]
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Secondary ID(s)
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NIS-ONL-IRE-2009/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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