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Accelerated Community Oncology Research Network, Inc. (ACORN), Initiates A Phase 2b Metastatic Breast Cancer Trial In Cooperation With Bayer And Onyx
Accelerated Community Oncology
Research Network, Inc. (ACORN), 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.
About Nexavar
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.
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.
Accelerated Community Oncology Research Network, Inc.
http://www.communityoncology.org
View drug information on Avastin; Gemzar; Nexavar.
Acceleratã de oncologie comunitare de cercetare, în reþea, Inc (ghindã), initiaza o faza 2b cancer de sân metastatic proces, în cooperare cu Bayer si onix - Accelerated Community Oncology Research Network, Inc. (ACORN), Initiates A Phase 2b Metastatic Breast Cancer Trial In Cooperation With Bayer And Onyx - articole medicale engleza - startsanatate