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

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

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: RAD001 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Efficacy of RAD001 in Metastatic Non-clear Cell Renal Cell Carcinoma
Study Start Date : January 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: RAD001
RAD001 10mg/day
Drug: RAD001
RAD001 10mg/day

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 months, 4 months, 6 months ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 2 months, 4 months, 6 months ]
  2. Disease-control rate [ Time Frame: 2 months, 4 months, 6 months ]
  3. Overall survival [ Time Frame: 2 months, 4 months, 6 months ]
  4. Metabolic response rate by FDG-PET [ Time Frame: 2 months, 4 months, 6 months ]
  5. Safety [ Time Frame: monthly ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00830895

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Se-Hoon Lee, Associate Professor, Seoul National University Hospital Identifier: NCT00830895     History of Changes
Other Study ID Numbers: SNUH-RENAL-0901
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013

Keywords provided by Se-Hoon Lee, Seoul National University Hospital:
Renal cell carcinoma
Non-clear cell
Metastatic, non-clear cell, renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents