Cell Therapeutics, Inc. (CTI) and Systems Medicine, LLC (SM), a wholly-owned subsidiary of CTI, announced the enrollment of the first patient to its complete phase Ib trial of brostallicin used in combination with either bevacizumab or irinotecan, for patients with advanced solid tumors.
Combining brostallicin with either bevacizumab or irinotecan is based on existing preclinical data that strongly supports taking these combinations into the clinic. A third treatment arm, which will include brostallicin in combination with an anticancer agent to be identified, will be added to the study. The agent will be identified from ongoing pharmacogenomic investigations using genomic-based search strategies to identify agents that are synergistic with brostallicin.
The trial, being conducted at multiple U.S. Oncology sites, is unique because of the novel "complete" phase I trial design and that genomic-driven discovery is being used to identify at least one of the agents for use with brostallicin.
The study design combines a new drug with existing therapies, selected based on genomic profiling, to increase the probability of seeing tumor responses in phase I and may enhance the overall success of the development program.
The complete phase I trial design, which was first reported at the 2007 Annual Meeting of the American Society for Clinical Oncology (ASCO), allows several combination phase 1 trials be conducted simultaneously.
"Most new drug approvals in development are in combination with existing regimens by phase III. By utilizing the complete phase I design, it is possible to rapidly explore several genomicly-guided combinations that could speed the development process and potentially bring benefit to more patients," said Daniel D. Von Hoff, M.D., F.A.C.P., Physician-in-Chief and Director of the Clinical Translational Research Division at the Translational Genomics Research Institute (TGen), Chief Scientific Officer of U.S. Oncology.
"With its extensive patient screening at multiple sites, U.S. Oncology is uniquely suited to conduct such studies with a single protocol and parallel multiple regimens," he continued.