![]() ![]() Serious adverse events thought possibly related to IMC-A12 included a grade 2 infusion-related reaction (2% one of 64 patients), thrombocytopenia (2% one of 64 patients), grade 3 hyperglycemia (2% one of 64 patients), and grade 1 pyrexia (2%, one of 64 patients). Arm C (all patients with KRAS wild type), however, showed no additional antitumor activity. Of the 21 patients randomly assigned to IMC-A12 plus cetuximab, one patient (with KRAS wild type) achieved a partial response, with disease control lasting 6.5 months. No antitumor activity was seen in the 23 patients treated with IMC-A12 monotherapy. ![]() Overall, 64 patients were treated (median age, 61 years range, 40 to 84 years): 23 patients in arm A, 21 in arm B, and 20 in arm C. Archived pretreatment tumor tissue was obtained when possible for KRAS, PIK3CA, and BRAF genotyping, and immunohistochemistry was obtained for pAKT as well as IGF-1R. Subsequently, arm C (same combination treatment as arm B) was added to include patients who had disease control on a prior anti-EGFR mAb and wild-type KRAS tumors. To evaluate the safety and efficacy of IMC-A12, a human monoclonal antibody (mAb) that blocks insulin-like growth factor receptor-1 (IGF-1R), as monotherapy or in combination with cetuximab in patients with metastatic refractory anti-epidermal growth factor receptor (EGFR) mAb colorectal cancer.Ī randomized, phase II study was performed in which patients in arm A received IMC-A12 10 mg/kg intravenously (IV) every 2 weeks, while patients in arm B received this same dose of IMC-A12 plus cetuximab 500 mg/m(2) IV every 2 weeks.
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