Open label treatment use protocol
New York, August 24, 2005 – Pfizer announced today the expansion of its treatment use program for its investigational, anti-cancer drug SUTENT® (sunitinib malate) to patients with metastatic renal cell carcinoma, or kidney cancer, who have not responded to standard therapies. The program will allow eligible patients with metastatic renal cell carcinoma to receive SUTENT from qualified, participating investigators at sites throughout the world.
SUTENT, an oral, multi-targeted tyrosine kinase inhibitor, is being made available through a treatment use protocol that has been approved by health authorities globally, including the U.S. Food and Drug Administration (FDA).
"We are encouraged by the promising results SUTENT has demonstrated in clinical trials," said Dr. Charles Baum, M.D., Ph.D., Global Clinical Leader, Pfizer Oncology. "The initiation of this treatment use protocol allows us to bring SUTENT to kidney cancer patients who may benefit from the therapy."
To be eligible for the SUTENT treatment use protocol, patients must have a clinical diagnosis of cytokine-refractory metastatic renal cell carcinoma and have not previously participated in a SUTENT clinical study. The first sites have opened to enrollment in the U.S. and Canada with many more sites to open in August, September and October in additional locations worldwide. Patients enrolled in the open label study will be monitored and data will be gathered to further assess the safety and benefit of SUTENT in patients with metastatic renal cell carcinoma. To learn more about open trial sites, patients and their physicians are encouraged to call the SUTENT clinical trial information line at 1-877-416-6248 or to visit www.pfizeroncology.com.
"Kidney cancer has traditionally been a difficult cancer to treat, and to date there have been few options to offer patients with this deadly disease," said Bill Bro, President of the Kidney Cancer Association. "We are pleased that continued research efforts and new potential treatment options such as SUTENT are bringing hope to kidney cancer patients in need."
GIST Treatment Use Program Continues
In addition to kidney cancer, SUTENT has been studied in patients with Gleevec-resistant Gastrointestinal Stromal Tumor or GIST. In 2004, Pfizer initiated a global, SUTENT expanded access program for patients with Gleevec-resistant GIST. Patients seeking information regarding this program should call 1-877-416-6248 or to visit www.pfizeroncology.com. Early phase II studies also have been conducted in patients with advanced non-small cell lung cancer, breast cancer, neuroendocrine tumors and a number of other indications.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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