Studies in the area of solid cancer therapy reported from College of Medicine
2007 NOV 19 -- Research findings, 'Phase I dose escalation study of the anti insulin-like growth factor-I receptor monoclonal antibody CP-751,871 in patients with refractory solid tumors,' are discussed in a new report. "This phase I study was undertaken to define the maximum tolerated dose, safety, and pharmacokinetic profile of CP-751,871 Using a rapid dose escalation design, patients with advanced nonhematologic malignancies were treated with CP-751,871 in four dose escalation cohorts. CP-751,871 was administered i.v. on day 1 of each 21-day cycle," scientists in the United States report. "Pharmacokinetic evaluation was done in all treatment cohorts during cycles 1 and 4 Twenty-four patients received 110 cycles at four dose levels. The maximum tolerated dose exceeded the maximal feasible dose of 20 mg/kg and, thus, was not identified. Treatment-related toxicities were generally mild. The most common adverse events were hyperglycemia, anorexia, nausea, elevated aspartate aminotransferase, elevated gamma-glutamyltransferase, diarrhea, hyperuracemia, and fatigue. At 20 mg/kg, 10 of 15 patients experienced stability of disease. Two of these patients experienced long-term stability. There were no objective responses. Pharmacokinetic analysis revealed a dose-dependent increase in CP-751,871 exposure and approximately 2-fold accumulation on repeated dosing in 21-day cycles. Plasma concentrations of CP-751,871 attained were several log-fold greater than the biologically active concentration. Treatment with CP-751,871 increased serum insulin and human growth hormone levels, with modest increases in serum glucose levels CP-751,871 has a favorable safety profile and was well tolerated when given in continuous cycles," wrote P. Haluska and colleagues, College of Medicine. The researchers concluded: "At the maximal feasible dose of 20 mg/kg, there was a moderate accumulation in plasma exposure, and most of the treated patients experienced stability of disease." Haluska and colleagues published their study in Clinical Cancer Research (Phase I dose escalation study of the anti insulin-like growth factor-I receptor monoclonal antibody CP-751,871 in patients with refractory solid tumors. Clinical Cancer Research, 2007;13(19):5834-40). For additional information, contact P. Haluska, Mayo Clinic College of Medicine, Rochester, Minnesota 55905 USA.. The publisher's contact information for the journal Clinical Cancer Research is: American Association Cancer Research, 615 Chestnut St., 17TH Floor, Philadelphia, PA 19106-4404, USA. Keywords: United States, Rochester, Solid Cancer Therapy, Biotechnology, Cancer Research, Clinical Trial Research, Drugs, Medical Device, Monoclonal Antibody, Oncology, Pharmaceuticals, Pharmacokinetics, Solid Cancers, Solid Carcinomas, Therapies, Therapy, Treatment. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.
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