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

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ClinicalTrials.gov Identifier: NCT00094029
Recruitment Status : Approved for marketing
First Posted : October 11, 2004
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Gastrointestinal Neoplasm Drug: Sutent

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
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
Study Start Date : September 2004
Primary Completion Date : October 2011
Study Completion Date : October 2011

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094029

  Show 118 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00094029     History of Changes
Other Study ID Numbers: A6181036
First Posted: October 11, 2004    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors