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
  Purpose

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


Condition Intervention Phase
Renal Cell Carcinoma
Drug: RAD001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 49
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001
RAD001 10mg/day
Drug: RAD001
RAD001 10mg/day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830895

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Se-Hoon Lee, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00830895     History of Changes
Other Study ID Numbers: SNUH-RENAL-0901
Study First Received: January 27, 2009
Last Updated: April 11, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Renal cell carcinoma
Non-clear cell
RAD001
Metastatic, non-clear cell, renal cell carcinoma

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

ClinicalTrials.gov processed this record on September 30, 2014