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 proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.
Nexavar is currently approved in more than 30 countries for liver cancer and in more than 60 countries for the treatment of patients with advanced kidney cancer. Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of other cancers, including non-small cell lung cancer (NSCLC), metastatic melanoma, breast cancer and as an adjuvant therapy for kidney cancer and liver cancer.
Important Safety Considerations For Patients Taking Nexavar
Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reported with Nexavar in patients with unresectable HCC were diarrhea, fatigue, abdominal pain, weight loss, anorexia, nausea and hand-foot skin reaction. Grade 3/4 adverse events were 45% for Nexavar vs. 32% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
For information about Nexavar including U.S. Nexavar prescribing information, visit http://www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).
Accelerated Community Oncology Research Network, Inc. (ACORN)
ACORN provides the scientific and clinical expertise and proven
experience to take a trial from concept to completion. ACORN's centralized
access can combine all of the functional areas of a CRO to conduct Phase I,
II, III, and IV oncology clinical trials. By employing the ACORN
centralized model of efficiency and advanced technology, pharmaceutical
companies and network members alike enjoy the advantage of a quicker and
more efficient research process.
Contact: Liz Conway
|SOURCE Accelerated Community Oncology Research Network, Inc.|
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