Home > Expanded Access > A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

Pfizer

A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

Official Title: 
A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate
Brief Summary: 
The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.
Detailed Description: 

Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181036 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.

Approved for marketing
Gastrointestinal Neoplasm

Drug: Sutent
Sutent, 25, 37.5, or 50 mg daily

Eligibility Criteria: 

Inclusion Criteria:

- Histologically proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to standard therapy

- Undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies

- Patient judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician

- Failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment

- Male or Female, 18 years or older

- Resolution of all acute toxicities of prior therapies

- Adequate organ function

Exclusion Criteria:

- Symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication

- Symptomatic central nervous system metastases

- Serious acute or chronic illness

- Current treatment on another clinical trial

- Pregnant or breastfeeding.

Eligibility Gender: 
All
Eligibility Age: 
Minimum: 18 Years
Countries: 
Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Venezuela
Locations: 

Pfizer Investigational Site
Duarte, California, 91010

Pfizer Investigational Site
Pasadena, California, 91105

Pfizer Investigational Site
San Francisco, California, 94115-1705

Pfizer Investigational Site
Santa Monica, California, 90404

Pfizer Investigational Site
Washington, District of Columbia, 20010-2931

Pfizer Investigational Site
Gainesville, Florida, 32610

Pfizer Investigational Site
Gainsville, Florida, 32610

Pfizer Investigational Site
Miami, Florida, 33136

Pfizer Investigational Site
Tampa, Florida, 33612

Pfizer Investigational Site
Niles, Illinois, 60714

Pfizer Investigational Site
Park Ridge, Illinois, 60068

Pfizer Investigational Site
Boston, Massachusetts, 02115

Pfizer Investigational Site
New Bedford, Massachusetts, 02741

Pfizer Investigational Site
Detroit, Michigan, 48201

Pfizer Investigational Site
Detroit, Michigan, 48202

Pfizer Investigational Site
Farmington Hills, Michigan, 48334

Pfizer Investigational Site
Minneapolis, Minnesota, 55455

Pfizer Investigational Site
Rochester, Minnesota, 55905

Pfizer Investigational Site
Creve Coeur, Missouri, 63141

Pfizer Investigational Site
St. Louis, Missouri, 63110-1010

Pfizer Investigational Site
St. Louis, Missouri, 63110-1094

Pfizer Investigational Site
Bronx, New York, 10466

Pfizer Investigational Site
Buffalo, New York, 14263

Pfizer Investigational Site
New York, New York, 10022

Pfizer Investigational Site
New York, New York, 10032

Pfizer Investigational Site
Durham, North Carolina, 27710

Pfizer Investigational Site
Portland, Oregon, 97201

Pfizer Investigational Site
Portland, Oregon, 97239

Pfizer Investigational Site
Dallas, Texas, 75246

Pfizer Investigational Site
Seattle, Washington, 98109

Pfizer Investigational Site
Seattle, Washington, 98195

Pfizer Investigational Site
Madison, Wisconsin, 53792

Pfizer CT.gov Call Center
Study Director
Pfizer

EA Number: 
MeSH Terms: 
Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms, Digestive System Neoplasms, Sunitinib
Disclaimer:
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.