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news.Peregrine Pharmaceuticals has received approval from the Drug Controller General of India for its Phase II clinical study of bavituximab, in combination with chemotherapy in patients with non-small cell lung cancer.
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The primary objective of the multi-center clinical trial is to assess the overall tumor response rate in non-small cell lung cancer (NSCLC) patients treated with the combination of bavituximab and carboplatin plus paclitaxel.
In the trial’s two-stage design, up to 21 patients with NSCLC will be enrolled initially. The study will then be expanded up to a total of 49 patients if promising results are observed in the initial cohort. Secondary objectives of the study include time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive bavituximab 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.