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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00830895
Other study ID # SNUH-RENAL-0901
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2009
Est. completion date December 2012

Study information

Verified date November 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date December 2012
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RAD001
RAD001 10mg/day

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival It is the time from treatment initiation until disease progression. 2 months, 4 months, 6 months
Secondary Response rate It is the percentage of patients whose cancer shrinks or disappears after treatment. 2 months, 4 months, 6 months
Secondary Disease-control rate 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. 2 months, 4 months, 6 months
Secondary Overall survival 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. 2 months, 4 months, 6 months
Secondary Metabolic response rate by FDG-PET It is assesed target lesions and non- target lesions by FDG-PET. 2 months, 4 months, 6 months
Secondary Safety monthly
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