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news.Peregrine Pharmaceuticals has said that its Phase II clinical protocol to study bavituximab in combination with the chemotherapy drug docetaxel in patients with metastatic breast cancer has been approved by the Drug Agency of the Ministry of Labour, Health and Social Affairs of Georgia.
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The open label, multi-center safety and efficacy trial is expected to begin enrolling patients by early 2008.
The primary objective of the trial is to assess the overall response rate to the combination of bavituximab with docetaxel, a chemotherapy drug commonly used in the treatment of metastatic breast cancer. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters.
In the trial’s two-stage design, up to 15 patients with metastatic breast cancer will be enrolled initially. The study will then be expanded up to a total of 46 patients if promising results are observed. The trial is expected to enroll patients at a minimum of three clinical trial sites.
Tumor response in this new 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.
Steven King, president and CEO of Peregrine, said: “We are eager to assess bavituximab’s potential in Phase II combination studies in a number of cancer indications, and we are very pleased to have received prompt regulatory approval to proceed with this breast cancer trial.”