Renal cell carcinoma
Conditions
Interventions
Titration of axitinib using Therapeutic Drug Monitoring (TDM)
Sponsors
Toranomon Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with metastatic or advanced renal cell carcinoma with histological confirmation of clear cell carcinoma or a component of clear cell. 2) Patients must have received one prior therapy with sunitinib and had disease progression on or within 6 months of stopping sunitinib therapy. (Prior cytokines therapy is permitted.) 3) Aged >= 20 4) ECOG performance status 0-1. 5) Patients with evaluable disease as defined by the RECIST criteria. 6) Patients with adequate bone marrow reserve (neutrophil count >=1500/mm3, hemoglobin level >= 9.0 g/dL, platelet count >= 75,000/mm3), adequate liver function (AST and ALT <= 100 IU/L, total bilirubin <= 2.0 mg/dL), kidney function (serum creatinine <=2.0 mg/dL. All laboratory data should be evaluated within 14 days before enrollment. 7) Expected survival >= 90 days. 8) Written informed consent obtained from patients.
Exclusion criteria
Exclusion criteria: 1) Patients who received VEGFR inhibitors (sorafenib, axitinib etc.) except for sunitinib, anti-VEGF antibody (bevacizumab), or mTOR inhibitors (everolimus or temsirolimus). 2) Patients who received palliative radiotherapy for bone metastasis within 2 weeks. 3) Patients who received major surgery within 4 weeks. 4) Patients who do not recover from side effects of sunitinib. 5) Patients with symptomatic brain metastases. 6) Patients with other active malignancies. 7) Patients with active infections. 8) Patients with serious complications (uncontrollable gastrointestinal bleeding, diabetics, cardiac diseases and hypertension etc.). 9) Patients who are undergoing dialysis. 10) Patients who developed pulmonary embolism, myocardial infarction, congestive heart failure and cerebrovascular disease within 12 months. 11) Patients with a history of serious drug allergy. 12) Patients who receive continuous corticosteroid administration. 13) Patients with serious mental problem. 14) Pregnant or lactating female. 15) Other patients evaluated to be inadequate to participate in this study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, response rate, time to treatment failure, safety | — |
Countries
Japan
Contacts
Public ContactYuji Miura
Toranomon Hospital Department of Medical Oncology
Outcome results
None listed