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Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00529802
First received: September 12, 2007
Last updated: August 12, 2010
Last verified: August 2010

September 12, 2007
August 12, 2010
September 2007
July 2010   (final data collection date for primary outcome measure)
to determine whether high uptake on FDG-PET is associated with tumor shrinkage [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
if high uptake on FDG-PET is associated with tumor shrinkage
Complete list of historical versions of study NCT00529802 on ClinicalTrials.gov Archive Site
to determine whether a change in FDG-PET in the context of RAD001 therapy is associated with tumor shrinkage [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer
An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer

The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Renal Cell
Drug: RAD001
take 2 tablets of RAD001 once a day by mouth (10 mg per day)
  • Experimental: A
    high uptake of FDG-PET
    Intervention: Drug: RAD001
  • Experimental: B
    low uptake of FDG-PET
    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
60
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Metastatic renal cancer refractory to sorafenib or sunitinib therapy
  • At least one measurable site of disease according to RECIST criteria that has not been previously irradiated.
  • 18 years of age or older
  • Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior standard systemic anticancer therapy and adequately recovered from the acute toxicities of any prior therapy.
  • World Health Organization (WHO) performance status <= 2
  • Adequate bone marrow function
  • Adequate liver function
  • Adequate creatinine clearance
  • Signed informed consent

Exclusion Criteria:

  • Prior treatment with any investigational drug within the previous 4 weeks
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
  • Patients who have a history of another primary malignancy ≤ 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • A known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
  • Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control from enrollment through 6 months following the end of treatment
  • Patients who have received prior treatment with an mTOR inhibitor.
  • Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00529802
15599B
Yes
Walter Stadler, M.D., The University of Chicago
University of Chicago
Novartis
Principal Investigator: Walter Stadler, MD University of Chicago
University of Chicago
August 2010

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