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

Sponsor: Pfizer

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT00094029

Provider View

This Expanded Access study allows GIST patients, ineligible for other SU011248 trials and unresponsive to standard treatments, to receive Sutent. Eligible participants must have failed prior imatinib treatment and have adequate organ function. Exclusions include recent severe cardiac events and CNS metastases. Sutent is administered in doses of 25, 37.5, or 50 mg daily.

Patient Parameters

Program Overview

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.

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.

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.

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