Phase II Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent Glioblastoma
The combination of sorafenib, valproic acid, and sildenafil may have therapeutic potential
for the treatment of GBM in the clinic. The combination of sorafenib and valproic acid is
predicated on the basis that sorafenib activity is enhanced by HDAC inhibition. The addition
of sildenafil is based on its ability to block ABCB1 and ABCG2 drug efflux pumps. As the
ABCG2 transporter is the primary transporter involved in the efflux of sorafenib at the BBB,
blocking its action is predicted to increase the concentration of sorafenib in the brain.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the efficacy of the combination of sorafenib (sorafenib tosylate), valproic acid, and sildenafil (sildenafil citrate), in terms of 6-month progression-free survival (PFS) in glioblastoma (GBM).
The Kaplan-Meier method will be used to describe the time to progression and the median time to progression will be estimated, along with its 95% confidence intervals, for the entire population and for PDGFRa expression, respectively. Cox regression analysis will be used to evaluate baseline characteristics and any potential covariates.
6 months
No
Asadullah Khan, MD
Principal Investigator
Virginia Commonwealth University
United States: Institutional Review Board
MCC-14816
NCT01817751
April 2013
December 2017
Name | Location |
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Virginia Commonwealth University | Richmond, Virginia |