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news.ImClone Systems, a fully integrated global biopharmaceutical company, has initiated patient enrollment for its disease-directed randomized Phase II clinical trial of IMC-A12 in patients with previously treated HER2-expressing locally advanced or metastatic breast cancer. IMC-A12 is ImClone's fully human, IgG1 anti-insulin-like growth factor-1 receptor monoclonal antibody.
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The primary objective of this Phase II study is to evaluate the antitumor activity of the combination of capecitabine and lapatinib with and without IMC-A12 in patients with HER2-expressing stages IIIB, IIIC, or IV breast cancer that has progressed on trastuzumab-containing treatment.
This study is being conducted by the North Central Cancer Treatment Group (NCCTG), a national clinical research group sponsored by the National Cancer Institute (NCI).
This Phase II study of IMC-A12 will enroll approximately 154 patients at more than 140 sites across the US. Patients will be randomized to receive treatment with either capecitabine and lapatinib or the same treatment plus IMC-A12. Treatment in both arms will be continued as long as potential benefit is shown. The primary endpoint of the study is progression-free survival.
Eric Rowinsky, chief medical officer and executive vice president of ImClone, said: “The NCCTG is seeking to determine if the anticancer activity of the combination with lapatinib and capecitabine, which is an approved treatment for women with HER2-expressing breast cancer that is no longer responsive to trastuzumab, can be improved by the addition of IMC-A12.”