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

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
Duarte, California, 91010 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastrointestinal Neoplasm
Sex
Females and Males
Age
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.
Show details

- 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.

NCT00094029
Pfizer
Approved for marketing
A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

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A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248
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.
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.
Expanded Access
Drug: Sutent
Sutent, 25, 37.5, or 50 mg daily
Dudeck O, Zeile M, Reichardt P, Pink D. Comparison of RECIST and Choi criteria for computed tomographic response evaluation in patients with advanced gastrointestinal stromal tumor treated with sunitinib. Ann Oncol. 2011 Aug;22(8):1828-33. doi: 10.1093/annonc/mdq696. Epub 2011 Feb 2.
 
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
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
 
 
NCT00094029
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

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