The Phase I portion of the trial is designed to determine the dose-limiting toxicity and maximum tolerated dose (MTD) of ispinesib monotherapy administered as a 1-hour intravenous infusion on days 1 and 15 of a 28-day cycle in female patients with locally advanced or metastatic adenocarcinoma of the breast who have not received prior chemotherapy.
Once an MTD is determined, the clinical trial will move into Phase II of the trial, which is designed to assess the overall response rate to ispinesib of patients with measurable locally advanced or metastatic breast cancer who have not received prior chemotherapy, using the response evaluation criteria in solid tumors (RECIST). Ispinesib will be administered as a 1-hour intravenous infusion on days 1 and 15 of a 28-day treatment cycle at the MTD determined in Phase I.
Andrew Wolff, senior vice president of clinical research and development and chief medical officer of Cytokinetics, said: “We anticipate we may see an amplified signal of anti-cancer activity on this treatment schedule in this chemotherapy-naive patient population.”