To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Investigational Kinase Inhibitor Continues to Show Efficacy in Patients with Solid Tumours: Presented at AACR-NCI-EORTC URL: http://www.pslgroup.com/dg/216A4A.htm Doctor's Guide November 2, 2007
By Crina Frincu-Mallos, PhD SAN FRANCISCO, CA -- November 2, 2007 -- Treatment with BAY 73-4506, a kinase inhibitor with anti-tumour and anti-angiogenic activity, continues to be well tolerated in patients with advanced solid tumours. In doses higher than 60 mg, the investigational agent is efficacious in colorectal carcinoma and ovarian cancer, in addition to the previously reported clinical activity in renal cell carcinoma and osteosarcoma, according to research presented here at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Alfred Frost, MD, Department of Medical Oncology, Tumor Biology Center, Albert Ludwigs University, Freiburg, Germany, presented an update on the BAY 73-4506 phase 1 study, first reported earlier this year at American Society for Clinical Oncology (ASCO) conference (Hedbom et al., 2007, JCO, 25: 3593). This is an ongoing, nonrandomised, single-agent, dose-escalation study of BAY 73-4506 in patients with advanced solid tumours, through which the investigators sought to evaluate the safety and efficacy profile of BAY 73-4506. As of September 4, 2007, a total of 41 patients with advanced solid tumours and progressive disease were participating in this study. The patients' median age is 64 years (range, 30 to 76 years) and the male to female ratio is 23:18. The most common types of cancer in the patients included, colorectal cancer (n = 12), melanoma (n = 5), renal cell carcinoma (n = 4), ovarian (n = 3), and pancreatic (n = 3). All 41 patients had prior surgery for tumour removal, and most had systemic therapy (n = 39) and radiotherapy (n = 19). The patients were divided into eight cohorts. The investigational agent was administered daily on the first 21 days of a 28-day cycle, in doses ranging from 10 mg to 220 mg. Dose limiting toxicities (DLTs) were hand-foot skin reaction (n = 7), thrombocytopenia (n = 3), diarrhea (n = 3), as well as leucopoenia, fatigue, cerebral bleeding, nausea, abdominal pain, thoracic pain, and asthma (one each). In addition, grade 3/4 infections such as dermatologic toxicity, hypertension, hypoglycaemia, and dyspnoea were reported. Based on the toxicity profile, Dr. Frost and colleagues decided to expand the BAY 73-4506 160 mg dose in order to enable a safety comparison with the highest dose level of 220 mg. Out of 33 evaluable patients, there were 2 (6%) partial responses (PRs), one in an osteosarcoma patient, and the other in a renal cell carcinoma patient. In addition, 20 (61%) patients had stable disease (SD) 7+ weeks after the start of the treatment with BAY 73-4506. All three ovarian cancer patients experienced SD with 5% to 30% decrease in tumour size compared to baseline, with duration between 100 and 200 days. In addition, 4/9 patients with colorectal carcinoma show similar decrease in tumour size, for >80 days. Based on these new results, the agent demonstrates very encouraging anti-tumour activity especially in colorectal and ovarian cancers, noted Dr. Frost and colleagues. However, 11 (33%) patients experienced disease progression while on BAY 73-4506 therapy. An expansion phase enrolling patients with colorectal carcinoma is planned in the near future, indicated Dr. Frost and colleagues. Funding for the study is provided by Bayer HealthCare Pharmaceuticals, West Haven, Connecticut, United States, and Bayer Schering Pharma, Wuppertal, Germany. [Presentation title: Phase I Study of BAY 73-4506, a kinase inhibitor that targets oncogenic and angiogenic kinases, in patients with advanced solid tumors. Abstract B85] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.