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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00529802
Other study ID # 15599B
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2007
Last updated March 27, 2018
Start date September 2007
Est. completion date July 2010

Study information

Verified date March 2018
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RAD001
take 2 tablets of RAD001 once a day by mouth (10 mg per day)

Locations

Country Name City State
United States Beth Israel Deaconess Med Ctr Boston Massachusetts
United States The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States University of Chicago Chicago Illinois
United States Oncology/Hematology Associates Peoria Illinois
United States Washington University Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chen JL, Appelbaum DE, Kocherginsky M, Cowey CL, Rathmell WK, McDermott DF, Stadler WM. FDG-PET as a predictive biomarker for therapy with everolimus in metastatic renal cell cancer. Cancer Med. 2013 Aug;2(4):545-52. doi: 10.1002/cam4.102. Epub 2013 Jul 1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Relative Tumor Size Change Following 8 Weeks of Therapy. The primary objective is to determine whether high SUV uptake on FDG-PET is associated with greater tumor shrinkage. Tumor size is defined as the sum of unidimensional tumor measurements from standard CT imaging calculated according to RECIST criteria. Tumor size is measured at baseline and after eight weeks of therapy. Tumor shrinkage is the relative change (%) in tumor size from baseline. 8 weeks
Secondary Percent Change in FDG-PETUptake Following 2 Weeks of Therapy The secondary objective was to explore whether an early change in FDG-PET uptake is associated with tumor shrinkage. Change in FDG-PET uptake was calculated using the baseline and 2-week FDG-PET scans. 2 weeks
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