Safety and Tolerability Study of RAD001 and LBH589 in All Solid Tumors With Enrichment for EBV Driven Tumors

Summary

The purpose of this study is: 1. To determine the optimal recommended phase II dose of two investigational study drugs, LBH589 and RAD001, given in combination in all solid tumors (With enrichment for EBV-Driven tumors). 2. To determine the pharmacokinetic profile of RAD001 in combination with two schedules of LBH589. 3. To assess the preliminary anti-tumor activity of RAD001 and LBH589. This study will also be exploring the hypothesis that HDACi and mTOR inhibitors abrogate the effects of key viral proteins, and switch the virus from a latent proliferative phase to a lytic phase. Immunologic correlates will also be examined to ascertain T-cell subpopulations and expression of HLA class molecules. DCE-MRI will be subsequently employed in dose expansion to examine antiangiogenic effects.

Timeline

Start

2010-03

Primary completion

2016-06

Completion

2018-12

Drugs

Indications