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news.ImClone Systems has announced that its disease-directed Phase II clinical trial in patients with advanced prostate cancer randomized to treatment with either IMC-A12 or IMC-1121B plus mitoxantrone and prednisone has commenced patient enrollment.
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This multicenter, randomized open-label Phase II single-arm study is enrolling patients with metastatic androgen-independent prostate cancer who have developed disease progression during or within 60 days of receiving docetaxel-based chemotherapy or demonstrated intolerance to docetaxel-based therapy.
A total of 132 patients are expected to be enrolled at various centers, including those that participate in the Department of Defense’s Prostate Cancer Consortium.
This Phase II study is designed to evaluate the efficacy and safety of both IMC-A12 and IMC-1121B combined with mitoxantrone and prednisone. IMC-A12 and IMC-1121B are administered weekly, whereas mitoxantrone is administered every three weeks with oral daily prednisone.
IMC-A12 and IMC-1121B are two therapeutic candidates in ImClone’s proprietary receptor-targeted antibody pipeline. IMC-A12 is ImClone’s fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody and IMC-1121B is its fully human, IgG1 anti-vascular growth factor receptor-2 (VEGFR-2) monoclonal antibody.