Pfizer Initiates Phase III Trial to Study Sunitinib Malate in Patients with Metastatic Colorectal Cancer
Pfizer announced today the initiation of a Phase III clinical
trial to evaluate the safety and efficacy of sunitinib malate, in
combination with a standard chemotherapy regimen, in patients with
metastatic colorectal cancer (mCRC) - cancer originating in the colon
that has spread to other parts of the body. In addition, new data from
a Phase I study being presented this week at the World Congress on
Gastrointestinal Cancer (WCGC) in Barcelona showed that sunitinib
malate is active and generally well-tolerated in combination with a
standard chemotherapy regimen, FOLFIRI, in previously untreated
patients with mCRC. These data support further evaluation of sunitinib
malate in mCRC in a Phase III program.
"We are encouraged by these data, which add to a growing body of
research demonstrating the activity and tolerability of sunitinib
malate in numerous cancers," said Charles Baum, MD PhD, head of
oncology development at Pfizer. "Based on these early findings
presented this week, Pfizer is committed to continued exploration of
sunitinib malate in the treatment of advanced colorectal cancer
through a global Phase III program."
Sunitinib Malate Phase III Trial in Colorectal Cancer
A multi-national Phase III study is currently open and enrolling
in Europe, Canada, Asia and South America and will include more than
700 patients to evaluate the safety and efficacy of sunitinib malate
combined with FOLFIRI, a standard chemotherapy regimen used in mCRC
comprised of fluorouracil (5-FU), folinic acid (leucovorin), and
irinotecan, compared with FOLFIRI plus placebo, in the first-line
treatment of patients with mCRC.
Sunitinib malate is a multi-kinase inhibitor which works by
inhibiting angiogenesis, the process by which tumors acquire blood
vessels bringing oxygen and nutrients needed for growth, and
proliferation, the process by which cells multiply.
Phase I Study in Metastatic Colorectal Cancer
New data presented this week from an ongoing, open-label Phase I
trial of 16 previously untreated mCRC patients randomized to three
distinct dosing regimens, determined the maximum tolerated dose (MTD)
for sunitinib malate of four weeks on treatment followed by two weeks
off (4/2) in combination with FOLFIRI was 37.5 mg/day. This regimen
appeared to be active and generally well-tolerated in patients who
have received no prior treatment for metastatic disease. Of the 10
patients who received this dosing regimen, four patients experienced
partial response to date and stable disease has been observed in six
patients. Treatment emergent grade greater than or equal to 3 adverse
events for patients on the sunitinib malate 37.5 mg/day 4/2 regimen
were one case of respiratory tract infection and two cases of
neutropenia without fever.
"Despite progress in recent years, colorectal cancer remains a
hard-to-treat cancer for which new options are sorely needed," said
Alfredo Carrato MD, PhD, Elche University Hospital and lead
investigator on the sunitinib malate multi-national Phase III trial in
mCRC. "These data support further research of sunitinib malate in
metastatic colorectal cancer, in an effort to potentially expand the
range of therapies available to physicians and patients."
For more information about sunitinib malate trials currently open
and enrolling, please visit www.ClinicalTrials.gov or
www.suntrials.com or call Pfizer Oncology's toll-free number at
001-646-277-4066.
DISCLOSURE NOTICE: The information contained in this release is as
of June 28, 2007. Pfizer assumes no obligation to update any
forward-looking statements contained in this release as the result of
new information or future events or developments.
This release contains forward-looking information that involves
substantial risks and uncertainties about a potential additional
indication for sunitinib malate, including its potential benefits.
Such risks and uncertainties include, among other things, the
uncertainties inherent in research and development; decisions by
regulatory authorities regarding whether and when to approve any
supplemental drug applications that may be filed for this additional
indication as well as their decisions regarding labeling and other
matters that could affect its availability or commercial potential;
and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended December
31, 2006 and in its reports on Form 10-Q and Form 8-K.