Observational research to decide optimal dose of Afatinib in patients with primary lung adenocarcinoma harbouring the sensitive mutation of epidermal growth factor receptor (EGFR) by pharmacokinetic analyses
Not Applicable
- Conditions
- Patients have primary lung adenocarcinoma harbouring the sensitive mutation of epidermal growth factor receptor (EGFR)
- Registration Number
- JPRN-UMIN000033549
- Lead Sponsor
- Department of Respiratory Medicine in the Center Hospital of the National Center for Global health and Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteria included: 1)Uncontrollable comorbid disease. 2)Symptomatic brain metastases 3)Active concomitant malignancy 4)Active infectious disease 5)Pregnant status or lactation 6)Acute or chronic diarrhea 7)Clinically active interstitial pneumonia 8)Acute myocardial ischemia within 3 months or unstable angina pectoris 9)Other ineligible status judged by medical oncologist
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To seek the pharmacological optimal dose of Afatinib in patients with primary lung adenocarcinoma harbouring the sensitive mutation of EGFR by pharmacokinetic analyses
- Secondary Outcome Measures
Name Time Method To seek the clinical optimal dose of Afatinib: Progression free survival (PFS),Time to Treatment failure (TTF), Health states evaluation; time with toxicity more than Grade 2 (TOX-G2), 20% duration of TOX-G2 among PFS (20% TOX-G2; TOX20). To examine the relationship between the efficacy of Afatinib and the copy number of EGFR mutation