Status:
COMPLETED
RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)
Lead Sponsor:
Seoul National University Hospital
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly)
- Subjects with metastatic legion
- Subjects aged 18 years or older
- Subjects whose ECOG performance status is 0 or 1
- 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
- Subjects who understand and provide a written informed consent
Exclusion
- Subjects who have been administered an mTOR inhibitor
- 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
- Subjects who participated in a clinical study using the study medication within 30 days before randomization
- Subjects with clinically uncontrolled central nervous system (CNS) metastasis
- Subjects with life expectancy of less than 3 months
- Subjects with interstitial pulmonary disease
- Subjects whose QTc interval is prolonged (QTc \> 450 msec for male or \> 470 msec for female)
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00830895
Start Date
January 1 2009
End Date
December 1 2012
Last Update
November 9 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, South Korea