Clinical Trials Sutent (SU11248)

View the treatment use trial sites

UNITED STATES

Sutent was approved in the United States on January 26, 2006 for the treatment of patients with gastrointestinal stromal tumors (GIST) whose disease has progressed or who are unable to tolerate treatment with Gleevec.

This page is intended for patients outside of the United States.

EmergingMed

The Pfizer Oncology Sutent development team has contracted with EmergingMed to offer free, confidential  clinical trial matching  & referral services to patients, families and health care professionals looking for Sutent clinical trials.

The Phase III clinical trial for GIST patients is closed, as the drug has successfully met its efficacy endpoint (see the message from Dr. George Demetri below). Patients needing access to the drug prior to regulatory approval in their country should contact EmergingMed. A "treatment use" study is still available for GIST patients outside of the United States with progressive disease and a Phase II trial testing continuous dosing is also available (includes the United States).

Please call EmergingMed's toll-free Clinical Trial Information Service at 1-800-620-6104 (Monday to Friday, 8:30 am to 6:00 pm eastern time) for assistance identifying and getting access to GIST clinical trials and GIST treatment use programs.  We ask that our international members use 1-877-416-6248 as a temporary number.  Please check the site for any changes for international callers.  You can also complete a GIST questionnaire at http://www.emergingmed.com.

Sites open for the treatment use trial are listed below and will be periodically updated, but for the most current information contact EmergingMed.

Message from Dr. George Demetri

SU11248 works, trial ends 7 months early

Why SU11248 might work if Gleevec fails

(1/29/05)

Since news travels quickly, I would like to take this opportunity to share with you personally some news of interest to the global community of patients, family members, friends, and colleagues interested in advancing the therapeutic options for patients with GIST.  I have already had inquiries about rumors heard at the ASCO GI Cancers meeting, and I wanted to get this information available to people as quickly as possible.

The data monitoring board (a team of experts totally separate from the investigators involved in a research study) met this week to evaluate the data obtained to date from the global Phase III randomized study of SU11248 for patients with GIST for whom Gleevec was not able to control the disease.

This data monitoring board for this study has now recommended that this trial can stop immediately due to having successfully met its efficacy endpoint. We have sent out a letter worldwide to the global team of SU11248 investigators so that they can get in touch with all of the patients on this trial and allow patients to obtain unblinded SU11248 immediately.

We will be working very hard to get more information to investigators and to the global community at large as soon as possible.  At this point, though, I can say that this should be a very positive step towards establishing beyond any doubt another therapeutic option for patients with GIST using a novel molecularly-targeted agent if Gleevec proves inadequate to control the disease.

As a community, we should all be grateful for the selfless trial participation and support of patients and families worldwide in this important trial, so that we could prove to any regulatory agency the value of this new therapy and thereby quickly make this agent available to patients and their physicians who wish to offer them the best care and the most effective options.

I am also tremendously indebted to the global network of collaborators and the team that has made this positive study a reality.  We must never stop in our quest to understand and defeat this disease, and to learn from GIST lessons that will be useful to improve the therapy of other cancers as well.

 With all best regards,

George

George D. Demetri, MD

Director, Center for Sarcoma and Bone Oncology Dana-Farber Cancer Institute

Follow-up message from Dr. Demetri
Sent: Tuesday, February 01, 2005 12:48 AM

Subject: Answers to many questions about SU11248


Dear Friends and Colleagues,


....Most of the questions have concerned how patients will access SU11248 while awaiting regulatory review of the data generated from the Phase III clinical trial that has now been stopped (and patient treatment continued in an unblinded, non-placebo fashion) upon the recommendation of the Data Monitoring Board on the basis of having successfully demonstrated the primary efficacy endpoint.

First, please rest assured that our global study team will be working with all due diligence and speed along with the study sponsor, Pfizer, to collect and fully analyze the study data and discuss these data with regulatory agencies worldwide. That is the right thing to do, and that is what we are fully dedicated to doing.

Second, while the data are being analyzed and evaluated fully, patients with GIST for whom Gleevec is no longer effective will be able to access SU11248 through the treatment use programs that are open at sites internationally.
There are several sites open now, and more sites being activated every week, so the best thing to do would be to contact either Dana-Farber's Sarcoma Center (617-632-5122) or the SU11248 Information Service toll free at 877-416-6248 to find out where there is a participating site that has been activated. We have set up a system to ensure that GIST patients can access this agent while awaiting the full and proper regulatory review of the data.

I hope this helps to address several of the concerns I have seen in emails and phone calls from many concerned individuals. Please let me know if there is anything else we can do at this early stage to help allay concerns and address questions. More specific information will, of course, be forthcoming when ready, but I hope this information will help us to care for and reassure our community of patients, family, and friends with GIST in the best possible way.

All the best,

George


George D. Demetri, MD
 

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Open treatment sites for the Treatment Use Study of SU11248 for Patients with Imatinib Mesylate (Gleevec) Resistant or Intolerant Malignant Gastrointestinal Stromal Tumors (GIST):

Call 1-800-620-6104 for the latest list of sites
This page will be updated periodically as new information comes to us

Australia, New South Wales
      Randwick,  New South Wales
      Camperdown,  New South Wales,  2050