A phase 1 clinical trial testing a novel combination therapy developed by scientists at VCU Massey Cancer Center slowed the growth of cancer in the majority of trial participants, who were patients with advanced solid tumors. Approximately 61 percent of these patients experienced some degree of tumor growth delay, with multiple partial responses and one complete response. A phase 2 study testing the same combination of the drugs sorafenib and pemetrexed in patients with recurrent or metastatic triple negative breast cancer is now open at Massey.
“Though phase 1 studies are designed to evaluate the safety of a new therapy, we had strong preclinical evidence suggesting this novel drug combination could work against a variety of cancers, so we hoped that we would see a response in our patients in this early phase trial,” said Andrew Poklepovic, M.D. (H.S.’07/M), lead investigator on the study. “With this trial, we established a safe dosing schedule, and we will now be testing the efficacy of the therapy in the phase 2 study.”
The results of the clinical trial were recently published online by the journal Oncotarget (PMID: 27213589). The study enrolled 37 patients between October 2011 and December 2014. Of those patients, 36 received treatment and 33 were evaluated for response. One patient had a complete response, meaning all detectable traces of the tumor disappeared, while four patients had a partial response, which means that the tumor volume shrank by at least 30 percent. The therapy stabilized disease progression in an additional 15 patients, with some of these patients responding for up to a year. The therapy was found to be particularly active in breast cancer patients.