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news.ImClone Systems, which develops and commercializes novel antibodies to treat cancer, has initiated patient enrollment for its disease-directed randomized Phase II clinical trial of IMC-A12, the company's fully human, IgG1 anti-insulin-like growth factor-1 receptor monoclonal antibody in women with advanced breast cancer.
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In this study, patients with hormone receptor expressing advanced breast therapy whose disease had progressed on an antiestrogen therapy are being randomized to treatment with either IMC-A12 as a single agent or IMC-A12 in combination with same dose and schedule of the last antiestrogen therapy to which their disease became refractory.
This multicenter randomized Phase II study will enroll approximately 90 women with advanced breast cancer whose disease had progressed on antiestrogen therapy.
The primary objective of this randomized Phase II study is to evaluate the efficacy of both IMC-A12 alone and IMC-A12 combined with the last antiestrogen therapy to which the patient’s cancer became refractory. The study will also characterize the safety of IMC-A12 given alone and combined with antiestrogen therapy. IMC-A12 will be administered on an every-two-week schedule.
Eric Rowinsky, chief medical officer and executive vice president of ImClone, said: “The study is efficiently designed to assess the activity of IMC-A12 as a single agent in breast cancer, as well as the relative activities of IMC-A12 and IMC-A12 plus antiestrogens following the development of progressive disease on the same therapy.”