Non-small cell lung cancer
Conditions
Interventions
Cohort A:Period 1, administration on two hours after meal
Period 2, on complete fasting.
Cohort B: Period 1, administration on complete fasting
Period 2, on two hours after meal.
Sponsors
Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with histologically or cytologically diagnosed NSCLC 2)Advanced or metastatic NSCLC 3)Patients aged >20 years 4)PS(ECOG) of 0 to 2 5)Patients planned to undergo erlotinib therapy as clinical practice 6)Patients who have recovered from the toxicities of any pior treatment 7)Having adequate organ function 8)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Active primary multiple cancer 2)serious concomitant disorders, including an active infection, active gastrointestinal bleeding, or ileus. 3)History of pulmonary fibrosis or interstitial lung disease 5)Patients who required other chemotherapy, rediotherapy, or immuno therapy 6)Patients who qre actively receiving warfarin, PPI, H2-blocker, or inducer or inhibitor of CYP3A4 7)Current smoker 13)Patients with hepatitis B or C virus or human immunodeficiency virus infection 8)pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of erlotinib between the administration on complete fasting and two hours after meal | — |
Countries
Japan
Contacts
Public ContactYutaka Fujiwara
National Cancer Center Hospital Division of Internal Medicine and Thoracic Oncology
Outcome results
None listed