Efficacy and Safety of Everolimus in Patients with Non-Clear Cell Renal Cell Carcinoma

Efficacy and Safety of Everolimus in Patients with Non-Clear Cell Renal Cell Carcinoma - Efficacy and Safety of Everolimus in Patients with Non-Clear Cell Renal Cell Carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000006248

Enrollment

Registered

2011-10-01

Start date

2011-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-clear cell renal cell carcinoma

Interventions

None listed

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 non-clear cell renal cell carcinoma 2) Patients who received a Patients with no previous history of chemotherapy, or molecularly targeted drug therapy excluded cytokine therapy 3) Patients who have at least one measurable foci on CT or MRI 4) 20 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
Progresstion Free Survival	—

Secondary

Measure	Time frame
Overall Survival , Objective Response Rate , Clinical Benefit Rate , immunity , Safety , QOL	—

Countries

Japan

Contacts

Public ContactShigeru Sakano

Yamaguchi University Graduate School of Medicine Department of Urology

0836222275

Outcome results