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Study Shows Advantages of Complete Phase Ib Trial Over Separate,Phase I Trials

HOUSTON, June 04, 2007 /PRNewswire/ -- A nationally renowned cancer researcher affiliated with the US Oncology Research Network presented a novel study design concept called a Complete Phase Ib clinical trial as a method to accelerate new agent development. Studies utilizing this design are currently being conducted through the network's innovative Translational Oncology Program (TOP). TOP is unique because it conducts early phase trials in a community setting. These types of trials are usually carried out in academic medical centers.

The study results were presented in a poster session by Daniel Von Hoff, M.D., Chief Scientific Officer for the US Oncology Research Network, at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) held June 2-5, 2007 in Chicago. In addition, 22 physicians and researchers affiliated with US Oncology participated in oral and poster presentations, moderated panels and published studies at this year's ASCO conference in Chicago. The researchers presented findings on a variety of disease states including lung, gastrointestinal, genitourinary, gynecologic, breast and melanoma.

The study, titled "The Complete Phase Ib Clinical Trial: A Method to Accelerate New Agent Development" tested the hypothesis that within a single protocol, several combination phase I trials could be conducted simultaneously

Background for this study indicates that the usual clinical development plan for a new agent (NA) includes a phase I monotherapy trial. However, because many new agents are eventually developed as part of a combination of agents, additional phase I trials assessing the new agent in combination with a standard agent are usually performed (usually as individual phase Ib studies).

Agents vary from study to study, based on preclinical modeling, which is the basis for which drugs are utilized in studies.

The design of the protocol is (assum
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