Peregrine Pharmaceuticals has reported completion of patient enrollment in its phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel in advanced breast cancer patients.
The trial’s planned total of 46 patients has been enrolled and patients are currently undergoing treatment and follow-up. The primary objective of the multi-center, open-label study is to assess the overall tumor response to the regimen of bavituximab in combination with carboplatin/paclitaxel.
Reportedly, the phase II trial of bavituximab in combination with carboplatin and paclitaxel in advanced breast cancer patients has a Simon two-stage design. In the first stage, 15 patients with advanced breast cancer were enrolled and treated with the combination regimen. Nine of the 14 (64%) evaluable patients demonstrated an objective tumor response according to RECIST criteria, exceeding the pre-specified primary efficacy endpoint needed to expand enrollment in the trial. An additional 31 patients were then enrolled to achieve the planned study total of 46 patients overall.
Secondary objectives of the study include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients in the study are evaluated regularly for tumor response according to RECIST criteria.
Joseph Shan, vice president of clinical and regulatory affairs at Peregrine, said: “Completion of patient enrollment in our second phase II breast cancer study marks another milestone for the bavituximab cancer program, with two of our three ongoing phase II trials now having completed enrollment.”
Separately, the company has announced issuance of a new US patent with claims covering the use of bavituximab in combination with a broad range of cancer therapeutic agents. Peregrine is currently conducting three separate phase II studies testing bavituximab in combination with docetaxel or carboplatin and paclitaxel in advanced breast and lung cancer patients.