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Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma

2014-08-27 03:14:26 | BioPortfolio

Summary

To compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology.

Description

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Advanced Non-clear Cell Renal Cell Carcinoma

Intervention

Everolimus, Sunitinib

Location

Duke Univeristy Medical Center
Durham
North Carolina
United States
27708

Status

Not yet recruiting

Source

Duke University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:26-0400

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Medical and Biotech [MESH] Definitions

A heterogeneous group of sporadic or hereditary carcinoma derived from cells of the KIDNEYS. There are several subtypes including the clear cells, the papillary, the chromophobe, the collecting duct, the spindle cells (sarcomatoid), or mixed cell-type carcinoma.

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A carbonic anhydrase and transmembrane protein that consists of an N-terminal PROTEOGLYCAN-like domain, a catalytic region, a single-pass transmembrane domain, and a short intracellular tail. It functions as a dimer and is expressed primarily by cells of the GASTROINTESTINAL TRACT; BILE DUCT EPITHELIUM; and GALL BLADDER. It is expressed at high levels in many solid tumors, especially CLEAR CELL RENAL CARCINOMA, in response to CELL HYPOXIA.

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