Multi-Center Phase II Clinical Trial on Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma after Failure of Treatment with 1st-Line TKI Therapy
- Conditions
- Renal cell carcinoma
- Registration Number
- JPRN-UMIN000004742
- Lead Sponsor
- Japanese Afinitor Clinical Trial Group of RCC (J-ACTOR)
- Brief Summary
A total of 57 patients were enrolled. Patients were administered 10 mg of everolimus q.d. orally. The primary efficacy endpoint was progression-free survival achieved by administration of everolimus. RESULTS: The median progression-free survival of patients administered everolimus was 5.03 months (95% confidence interval: 3.70-6.20). The median overall survival was not reached. The objective response rate was 9.4% (95% confidence interval: 3.1-20.7). The progression-free survival in the group of <100% relative dose intensity was 6.70 months (95% confidence interval: 4.13-11.60), and that in the group of 100% relative dose intensity was 3.77 months (hazard ratio: 2.79, 95% confidence interval: 2.77-5.63). The commonly observed adverse events and laboratory abnormalities were stomatitis (49.1%), hypertriglyceridemia (26.4%), interstitial lung disease (26.4%), anemia (22.6%) and hypercholesterolemia (22.6%). CONCLUSION: The median progression-free survival was almost similar to that recorded in the RECORD-1 study, whereas prolongation of overall survival was observed in the present study compared with the RECORD-1 study. The treatment outcomes of first-line vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy and second-line everolimus treatment in Japanese patients were successfully established in the present study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS
- Secondary Outcome Measures
Name Time Method 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) HRQO