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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Se-Hoon Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00830895
First received: January 27, 2009
Last updated: April 11, 2013
Last verified: April 2013

January 27, 2009
April 11, 2013
January 2009
October 2010   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00830895 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Disease-control rate [ Time Frame: 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Metabolic response rate by FDG-PET [ Time Frame: 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Carcinoma
Drug: RAD001
RAD001 10mg/day
Experimental: RAD001
RAD001 10mg/day
Intervention: Drug: RAD001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00830895
SNUH-RENAL-0901
No
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