ALK fusion gene positive NSCLC
Conditions
Interventions
We evaluate pharmacokinetics of Crizotinib.
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The patient diagnosed as ALK fusion gene positive Non-small cell lung cancer with histological or cytological diagnosis 2.The recurrence and progressive Non-small cell lung cancer which is unresectable 3.The patient who is going to take Crizotinib 250mg twice a day 4.A patiet at least 20 years at the registration within 14 day before registration 5.Laboratory data within 14 days fill following all, total bilirubin : 2.0 or less mg/dl, AST (GOT) : 150 or less IU/L, ALT (GPT) : 150 or less IU/L, serum creatinine : 2.0 or less mg/dL, SpO2 : 90 or more % (room air) 6.The patient has provided signed informed consent
Exclusion criteria
Exclusion criteria: 1. The patients need to concurrent treatment with other anticancer therapy, including other chemotherapy, radiotherapy, or immunotherapy. 2. Preexisting interstitial lung disease (ILD) 3. Known positive test results for human immunodeficiency virus (HIV),hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCVb) 4. The digestive disorder which influences absorption of Crizotinib, malabsorption syndrome, gastric resection including stomach subtotal excision, or extensive small intestine resection. 5. Oral feeding difficulty 6. The pregnant patient, patient suspected of being pregnant, or breastfeeding. 7. The patient whom the principal investigator or the doctor in attendance judged not to be suitable as an experimental object
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the correlation PK/PD with effects and adverse events of Crizotinib. | — |
Countries
Japan
Contacts
Public ContactYutaka Fujiwara
National Cancer Center Hospital Thoracic Oncology
Outcome results
None listed