A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248
Basic Trial Information
|No phase specified||Treatment||18 and over||A6181036|
TRIAL STATUS: Approved-not yet active
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.
Further Study Information
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.
Histologically proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to
Undergone screening and found to be ineligible for participation in ongoing SU011248
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
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.
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00094029
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.