An observational study of serum and cerebrospinal fluid concentrations of osimertinib for the treatment of lung cancer harboring EGFR activating and T790M mutations.

Not Applicable

• Conditions: ung Cancer

• Registration Number: JPRN-UMIN000024327
• Lead Sponsor: Miyagi Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-17
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1. Having an evidence of ILD or pulmonary fibrosis complication on chest X-ray. 2. With severe complication. 1)Uncontrollable angina pectoris, myocardial infarction, or heart failure. 2)Uncontrollable diabetes or hypertension. 3)Severe infectious disease. 4)gastrointestinal dysfunction with severe diarrhea. 3. Impossible to take drugs orally. 4. Inadequate case considered from drug package insert of osimertinib.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the relationship of serum osimertinib concentration and toxicity

Secondary Outcome Measures

Name	Time	Method
1)To evaluate the relationship of serum osimertinib concentration and efficacy. 2)To evaluate the relationships of CSF concentration of osimertinib and CNS toxicity. 3)To cleat the pharmacogenomics of osimertinib.