Study record managers: refer to the Data Element Definitions if submitting registration or information. Study site s and of patients planned: Approximately patients will be recruited in Europe. The recruitment will be increased beyond that as the study will expand in other regions of the world America, Asia. Study De This will be an open-label, single-arm, multinational, multicenter, real world treatment study.
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AZD will be administered orally as one 80 mg tablet once a day. Duration of IP administration: Patients may continue to receive AZD as long as they continue to show clinical benefit, as judged by the investigator, and in the absence of discontinuation criteria. The study arab be closed in each participating country as soon as possible following national reimbursement of AZD in that country up to a max of 90 days post reimbursement. Enrolment will be closed within 6 months after market approval in that country or at national reimbursement, whichever is sooner. Patients withdrawing from the treatment prior to national reimbursement sex be followed up as part of this study.
Patients on treatment will receive want supply until documented disease progression as per investigator assessment. In the event that adult reimbursement should not be granted following a reasonable time after market approval in the country, the study will be closed in a maximum period of 18 months after the last patient is enrolled in that country. If applicable, 35016 for conversion to commercial drug will be agreed with local bodies which may include regulatory agencies, ethics committees, and institutions.
Patient will be followed until death or lost to follow-up. Descriptive statistics will be used for all variables, as appropriate. Continuous variables will be summarised by the of observations, mean, standard deviation, median, minimum, and maximum. Categorical variables will be summarised by frequency counts and percentages for each category.
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Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information.
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Real world treatment study of azd for advanced/metastatic egfr tm mutation nsclc (astris)
Last Update Posted : March 17, Study Description. Detailed Description:. Drug Information available for: Osimertinib. FDA Resources.
Arms and Interventions. Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms.
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Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Patients may have also received additional lines of treatment World Health Organization WHO performance status Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline please refer to IB for guidance ECG recording at baseline showing absence of any cardiac abnormality as per exclusion criterion 6 Female patients of childbearing potential must be using adequate contraceptive measures, must not be breast feeding, and must have a negative pregnancy test prior to start of dosing.
A safety and tolerability study of assisted and self-administered subcutaneous (sc) herceptin (trastuzumab) as adjuvant therapy in early human epidermal growth factor receptor 2 (her2)-positive breast cancer (safeher)
Otherwise, they must have evidence of nonchildbearing potential Male patients must be willing to use barrier contraception, i. Contacts and Locations. 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. More Information.
National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Lung Cancer.
Phase 3. Study Type :. Interventional Clinical Trial.
Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :.
Actual Study Completion Date :. June 17, Key Record Dates.