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

Phase 2 Completed 60 enrolled University of Chicago Novartis · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2007-09
Primary completion: 2010-07
Completion: 2010-07

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Low Uptake vs High Uptake; p = 0.69; Mean Difference (Net) 1.9 (95% CI -9.3 to 13.23); t-test, 2 sided NCT00529802 ↗

Publications

Results 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 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	10 mg	Oral