Renal cell carcinoma
Conditions
Interventions
Everolimus 10 mg will be administered once daily under fasting condition. The dosage will be adjusted according to the discontinuation, reduction or withdrawal criteria due to adverse events.
Sponsors
Japanese Afinitor Clinical Trial Group of RCC (J-ACTOR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with unresectable or metastatic renal cell carcinoma who have confirmed histological or cytological diagnosis of clear cell renal cell carcinoma 2) Patients who received a singe agent of TKI treatment (sorafenib, sunitinib, pazopanib, axitinib) as 1st-line therapy and who meet all of the following criteria - Patients with cancer progression during or after TKI treatment and who received the last dose of TKI within 8 weeks before enrollment Disease progression is evaluated based on overall response using RECIST v.1.0; patients with PD are eligible for enrollment and investigator's assessment is also acceptable - Patients who did not receive cytokine or chemotherapy 1 year prior to TKI treatment - Patients who did not receive cytokine or chemotherapy as concomitant medication 3) Patients who have at least one measurable foci on CT or MRI 4) 18 years old or older 5) ECOG PS 0-1 6) No interstitial pneumonia in the lungs observed on chest CT 7) Patients with sufficient hematopoietic function who meet the following all criteria - Neutrophil >= 1,500/mm3 - Platelet >= 10 times 104/mm3 - Hemoglobin > 9.0 g/dL 8) Patients with sufficient hepatic functions who meet the following all criteria - Total-bilirubin <= 1.5 times ULN - AST and ALT <= 2.5 times ULN (patients with hepatic metastasis <= 5.0 times ULN) 9) Patients with sufficient renal function who meet the following criterion Serum creatinine <= 1.5 times ULN 10) Patients whose fasting blood glucose <= 1.5 times ULN and blood glucose level is under control 11) Patients who meet the following all criteria - Total-cholesterol <= 400 mg/dL - Triglycerides <= 5.0 times ULN 12) More than 3 months of life expectancy 13) Patients (or legal representative in case of minority) who gave informed consent for participation to the study after they received explanation of the briefing document
Exclusion criteria
Exclusion criteria: 1) Patients with history of hypersensitivity against everolimus or sirolimus derivative 2) Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby 3) Patients who are on long-term treatment with corticosteroid or immunosuppressant 4) Patients treated for another primary malignancy within 3 years of enrollment 5) Patients judged ineligible to participate in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival from the initiation of TKI treatment as 1st-line therapy 2) Overall survival from the initiation of everolimus treatment 3) ORR 4) TTF 5) Safety profile 6) HRQOL | — |
Countries
Japan
Contacts
Public ContactTakayuki Sugiyama
Hamamatsu University School of Medicine Department of Urology
Outcome results
None listed