Study of RAD001 in Soft Tissue Extremity and/or Retroperitoneal Sarcomas



Status:Archived
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:January 2010
End Date:February 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Single-arm, Open Label Phase II Study of RAD001 in Soft Tissue Extremity and/or Retroperitoneal Sarcomas


The goal of this clinical research study is to learn if the study drug RAD001 can stop or
slow the growth of resectable soft tissue sarcoma. The patient's physical state, their
symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study
will help the research team decide if RAD001 is safe and effective in patients with this
condition. The study drug, RAD001, is made by Novartis Pharmaceuticals Corporation.


A single-arm, open label, proof of principle phase II study exploring the efficacy of RAD001
in resectable soft tissue sarcomas either in the extremities, trunk or retroperitoneum.
Patients with resectable sarcomas as detailed below will have a core biopsy for molecular
markers prior to therapy with RAD001 10mg PO daily x 4 weeks. The patients will then be
brought to surgery for definitive resection within 21 days of the end of therapy with
RAD001. Pharmacodynamic markers as detailed in the objectives will be assessed in the
laboratory.

Patients will be numbered sequentially from 1 to 40, or more if there are patients that drop
out due to drug toxicity, with the goal of achieving 40 pts in accrual for evaluation of the
pre- and post-treatment tumor samples for Pharmacodynamic assays.


We found this trial at
1
site
H. Lee Moffitt Cancer Center & Research Institute
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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