WAYNE, N.J. and EMERYVILLE, Calif., Feb. 24, 2011 /PRNewswire/
— Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc.
(Nasdaq:
ONXX) today announced the companies have begun enrolling
patients in a Phase 3 randomized, double-blind, placebo-controlled
trial evaluating Nexavar® (sorafenib) tablets in combination
with the oral chemotherapeutic agent, capecitabine, versus placebo
plus capecitabine for the treatment of patients with advanced
breast cancer. This Phase 3 trial was initiated based on the
results from a cooperative group-sponsored Phase 2 clinical trial
evaluating Nexavar in combination with capecitabine in patients
with advanced breast cancer.
“This Phase 3 trial is an important milestone in our development
of Nexavar as it provides an opportunity to evaluate Nexavar in
this patient population,” said Dr. Dimitris Voliotis, Vice
President, Global Clinical Development Oncology, Bayer HealthCare.
“We look forward to continuing our breast cancer clinical trial
program, which includes two ongoing cooperative group-sponsored
Phase 2 trials.”
Phase 3 Trial Design
The RESILIENCE (Phase 3 TRial Comparing
CapecitabinE in Combination with SorafenIb or
PLacebo for Treatment of Locally Advanced or
MetastatIc HER2–Negative Breast
CancEr) trial is a randomized, double-blind,
placebo-controlled Phase 3 study planned to enroll 519 patients in
more than 20 countries including the United States, Brazil, Japan
and Australia. The study will evaluate Nexavar in combination with
capecitabine in patients with locally advanced or metastatic HER-2
negative breast cancer who are resistant to or have failed prior
taxane and an anthracycline or for whom further anthracycline is
not indicated. The primary endpoint of the study is
progression-free survival. Secondary endpoints include
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