MEMPHIS, Tenn., Feb. 14 /PRNewswire/ -- Accelerated Community Oncology Research Network, Inc. (ACORN), today announced the initiation of a Phase 2b clinical trial evaluating the efficacy of Nexavar(R) (sorafenib) tablets in combination with the anticancer drug gemcitabine (Gemzar(R)) in patients with metastatic breast cancer whose cancer has progressed during or after treatment with bevacizumab (Avastin(R)).
The double-blind, randomized trial will enroll a total of 220 patients at approximately 45 sites in approximately 20 states and will assess efficacy, safety and patient quality of life as endpoints. Patients will be randomly assigned to receive either Nexavar and gemcitabine, or placebo and gemcitabine.
"This trial will help to establish the value of tyrosine kinase inhibition of the VEGF receptor after tumors have progressed on bevacizumab, an increasingly likely clinical scenario in patients with metastatic breast cancer," said Dr. Clifford Hudis, lead investigator, chief of the breast cancer medicine service, Memorial Sloan-Kettering Cancer Center.
"In addition to more efficient clinical trial management services, the ACORN network of community oncology practices provides Onyx and Bayer with dedicated principal investigators who serve a demographically broad-based patient population," said Dr. Lee Schwartzberg, medical monitor for the trial.
ACORN will enroll research sites, provide contract and budgeting services, foster the accrual of patients at the site level, collect data and monitor its accuracy, and provide overall project management for the trial.
Nexavar targets both the tumor cell and tumor vasculature. In
preclinical studies, Nexavar has been shown to target members of two
classes of kinases known to be involved in both cell prolifer
|SOURCE Accelerated Community Oncology Research Network, Inc.|
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