A Phase I/II Study of the HDAC Inhibitor LBH589 in Combination with the mTOR Inhibitor Everolimus (RAD001) in Metastatic Renal Cell Carcinoma
Title A Phase I/II Study of the HDAC Inhibitor LBH589 in Combination with the mTOR Inhibitor Everolimus (RAD001) in Metastatic Renal Cell Carcinoma
Contact JBart
Principal Investigator Roberto Pili, MD
Study Number 146308
PhaseI/II
Summary
Phase I of this study will evaluate the safety and tolerability of three possible dose levels. The two drug regimen will be given as a three week cycle. A minimum of 6 patients will be treated at each dose level. Dose level toxicities will be evaluated to determine dose modifications and the recommended dose level for Phase II.
Phase II will evaluate the effects of this drug combination on the progression free survival in patients with metastatic RCC.
Eligibility
- Patients must have histologically confirmed metastatic or unresectable renal cell carcinoma. Predominant clear cell component is required.
- Patients must have metastatic disease which has progressed on or within 6 months of stopping treatment VEGFR receptor tyrosine kinase inhibitors. Prior therapy with bevacizumab, interleukin 2 or interferon alpha is also permitted.
- Patients must meet required laboratory criteria.
- Baseline MUGA or ECHO must demonstrate LVEF > the lower limit of the institutional normal.
- Pure papillary and chromophobe renal carcinoma, collecting duct tumors and transitional cell carcinoma are not eligible.
