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


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Study Location
Pfizer Investigational Site
Duarte, California, 91010, United States


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastrointestinal Neoplasm
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.


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Advanced Information
Descriptive Information
Brief Title A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248
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.
Study Type Expanded Access
Intervention Drug: Sutent
Sutent, 25, 37.5, or 50 mg daily
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location 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
Removed Location Countries  
Administrative Information
NCT Number NCT00094029
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2012