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

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00094029
First received: October 8, 2004
Last updated: March 8, 2012
Last verified: March 2012

October 8, 2004
March 8, 2012
September 2004
October 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00094029 on ClinicalTrials.gov Archive Site
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Not Provided
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A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248
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

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
Not Provided
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Gastrointestinal Neoplasm
Drug: Sutent
Sutent, 25, 37.5, or 50 mg daily
Not Provided
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. Epub 2011 Feb 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Approved for marketing
Not Provided
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   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,   Venezuela
 
NCT00094029
A6181036
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP