Renal Cell Carcinoma
Conditions
Keywords
Renal cell carcinoma, Non-clear cell, RAD001, Metastatic, non-clear cell, renal cell carcinoma
Brief summary
To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma
Interventions
DRUGRAD001
RAD001 10mg/day
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly) 2. Subjects with metastatic legion 3. Subjects aged 18 years or older 4. Subjects whose ECOG performance status is 0 or 1 5. Subjects who have laboratory value below; Hematology * Neutrophil \>= 1.5 x 109/L * Platelet \>= 75 x 109/L * Hemoglobin \>= 9 g/dL Liver function tests * Total bilirubin ≤ 1.5 xULN * AST, ALT ≤ 2.5 xULN * Alkaline phosphatase ≤ 2.5 xULN Renal function tests * Creatinine clearance \>= 30 mL/min 6. Subjects who understand and provide a written informed consent
Exclusion criteria
1. Subjects who have been administered an mTOR inhibitor 2. Pregnant or nursing women, and women of childbearing potential must use appropriate contraception for the study period and the result of their pregnancy test performed within 14 days before enrollment must be negative 3. Subjects who participated in a clinical study using the study medication within 30 days before randomization 4. Subjects with clinically uncontrolled central nervous system (CNS) metastasis 5. Subjects with life expectancy of less than 3 months 6. Subjects with interstitial pulmonary disease 7. Subjects whose QTc interval is prolonged (QTc \> 450 msec for male or \> 470 msec for female) 8. Other serious diseases or medical conditions Heart disease unstable despite treatment History of myocardial infarction within six months before the study History of serious neurological or psychological disorder including dementia or seizure Active peptic ulcer which cannot be controlled by a drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 months, 4 months, 6 months | It is the time from treatment initiation until disease progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 2 months, 4 months, 6 months | It is the percentage of patients whose cancer shrinks or disappears after treatment. |
| Disease-control rate | 2 months, 4 months, 6 months | It is the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention. |
| Overall survival | 2 months, 4 months, 6 months | The length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive. |
| Metabolic response rate by FDG-PET | 2 months, 4 months, 6 months | It is assesed target lesions and non- target lesions by FDG-PET. |
| Safety | monthly | — |
Countries
South Korea
Outcome results
None listed