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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
No phase specifiedTreatmentNot yet active18 and overA6181036
NCI-2010-01834, NCT00094029

Trial Description


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.

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.

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Serenex Inc

    Link to the current ClinicalTrials.gov record.
    NLM Identifier 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.