PeregrineInitiates Clinical Trial Of Bavituximab In Patients With Advanced Breast Cancer
Peregrine Pharmaceuticals has begun patient screening in a clinical trial designed to evaluate the safety and efficacy of bavituximab in combination with chemotherapy in patients with advanced breast cancer. The primary objective of the study is to assess the overall response rate to the combination of bavituximab with docetaxel, a chemotherapy drug commonly used in advanced breast cancer. The multi-center clinical trial is being conducted in the Republic of Georgia.
In the trial's two-stage design, up to 15 patients with advanced breast cancer will be enrolled initially. The study will then be expanded up to a total of 46 patients if promising results are observed. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable.
"We are delighted that patient screening has begun in this Phase II study that provides us with an excellent opportunity to further evaluate the potential efficacy of bavituximab in combination with chemotherapy in treating breast cancer," said Steven W. King, president and CEO of Peregrine. "This trial should allow us to build on the encouraging results we observed in breast cancer patients in an earlier bavituximab combination therapy study. We look forward to learning more about bavituximab's potential in this important indication in the coming months as we advance both this study and a second breast cancer trial evaluating a different combination therapy regimen."
Tumor response in this Phase II study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards.