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news.Peregrine Pharmaceuticals has reported that its Phase II clinical protocol to study bavituximab in combination with chemotherapy in patients with advanced breast cancer has been approved by the Drug Controller General of India or DCGI.
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The primary objective of the multi-center clinical trial is to assess the overall response rate to the combination of bavituximab with carboplatin and paclitaxel, chemotherapy drugs commonly used in the treatment of breast cancer.
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 of the study 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.
Tumor response in this 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.