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RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00830895
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : April 12, 2013
Information provided by (Responsible Party):
Se-Hoon Lee, Seoul National University Hospital

January 27, 2009
January 28, 2009
April 12, 2013
January 2009
October 2010   (Final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 2 months, 4 months, 6 months ]
Same as current
Complete list of historical versions of study NCT00830895 on Archive Site
  • Response rate [ Time Frame: 2 months, 4 months, 6 months ]
  • Disease-control rate [ Time Frame: 2 months, 4 months, 6 months ]
  • Overall survival [ Time Frame: 2 months, 4 months, 6 months ]
  • Metabolic response rate by FDG-PET [ Time Frame: 2 months, 4 months, 6 months ]
  • Safety [ Time Frame: monthly ]
Same as current
Not Provided
Not Provided
RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)
A Phase II Study to Evaluate the Efficacy of RAD001 in Metastatic Non-clear Cell Renal Cell Carcinoma
To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cell Carcinoma
Drug: RAD001
RAD001 10mg/day
Experimental: RAD001
RAD001 10mg/day
Intervention: Drug: RAD001
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
October 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Se-Hoon Lee, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP