The results were from stage one of a two-stage phase II trial of ispinesib administered as monotherapy in the treatment head and neck cancer. This two-stage clinical trial was designed to require a minimum of one confirmed partial or complete response out of 19 patients in order to proceed to stage two. At the interim analysis after stage one of this clinical trial, ispinesib in patients at this dosing level did not satisfy the criteria for advancement.
The phase II clinical trial was designed to evaluate the safety and efficacy of ispinesib as an intravenous one hour infusion once every 21 days in patients with head and neck, who had received no more than one prior chemotherapy regimen. The best overall response to date in this clinical trial was disease stabilization, which was observed in five of the 19 patients.
Two patients died in the study. One death in a patient with a non-neutropenic infection was attributed to progressive disease, while the other death was attributed to pneumonia.
This clinical trial was conducted by the US National Cancer Institute under a collaboration with GlaxoSmithKline.