Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2009-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RAD001
RAD001 10mg/day
RAD001
RAD001 10mg/day
Interventions
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RAD001
RAD001 10mg/day
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Se-Hoon Lee
Associate Professor
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Koh Y, Lim HY, Ahn JH, Lee JL, Rha SY, Kim YJ, Kim TM, Lee SH. Phase II trial of everolimus for the treatment of nonclear-cell renal cell carcinoma. Ann Oncol. 2013 Apr;24(4):1026-31. doi: 10.1093/annonc/mds582. Epub 2012 Nov 23.
Other Identifiers
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SNUH-RENAL-0901
Identifier Type: -
Identifier Source: org_study_id
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