A Randomized Phase II Study of Afinitor (RAD001) vs. Sutent (Sunitinib) in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma (ASPEN)
This will be an international (USA, Canada, and UK) open-label, outpatient, multicenter,
randomized study of treatment with RAD001 (everolimus (Afinitor®) or sunitinib (Sutent®) in
subjects with mRCC and non-clear cell histology. Special emphasis is placed on papillary
and chromophobe histologies while sarcomatoid clear cell variants, medullary, and collecting
duct carcinomas will be excluded (see eligibility). Subjects may continue receiving study
drugs until disease progression, unacceptable toxicities, or withdrawal of consent, for a
maximum of 24 months. Continuation of study assigned treatment will be allowed beyond 24
months at the discretion of the sponsor. Stratification variables will include histology
(papillary vs. chromophobe) and Motzer risk criteria (0, 1-2, and 3). Tumor progression will
be assessed locally and by independent review, in strict accordance with Response Evaluation
Criteria in Solid Tumors (RECIST 1.1) criteria measured every 12 weeks. At the time of
progression, subjects will be taken off study other than simple administrative mortality
follow-up. Primary pathologic samples and plasma/urine angiokine levels at baseline and
over time will be collected and stored centrally for biomarker analysis.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Anti-tumor activity
The primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST criteria. In addition, the rates of PFS will be compared at 6, 12 and 24 months.
6, 12 and 24 months
No
Andrew Armstrong, MD, ScM
Principal Investigator
Duke University
United States: Institutional Review Board
Pro00020714
NCT01108445
September 2010
September 2015
Name | Location |
---|---|
Oregon Health & Science University | Portland, Oregon 97201 |
Cleveland Clinic | Cleveland, Ohio 44195 |
University of Chicago | Chicago, Illinois 60637 |
Duke Univeristy Medical Center | Durham, North Carolina 27710 |
Karmanos Cancer Institute/Wayne State University | Detroit, Michigan |
SCRI | Nashville, Tennessee 37203 |
Indiana University Melvin and Bran Simon Cancer Center | Indianapolis, Indiana 46202 |
Washington Univ in St. Louis-School of Medicine | St. Louis, Missouri 63110 |
The Vanderbilt Clinic, Henry-Joyce Cancer Center | Nashville, Tennessee 37212 |