The companies have initiated this trial based on preliminary safety results from ongoing phase Ib trials evaluating belinostat in combination with Velcade.
The phase II trial will assess the combination therapy in patients who are refractory to or who have rapidly relapsed from at least one previous Velcade regimen. Preliminary results of the phase II trial are anticipated by the end of 2007.
In vitro studies have shown that histone deacetylase (HDAC) inhibitors and Velcade, when combined, act synergistically through independent mechanisms leading to enhanced killing of cancer cells.
Intravenous belinostat is currently being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T- and B-cell lymphomas, AML, mesothelioma, liver, colorectal, ovarian cancers, either alone or in combination with anticancer therapies.