IMATINIB MESYLATE-RESISTANT OR INTOLERANT MALIGNANT GASTROINTESTINAL TUMOR

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a dual-arm, double-blind, placebo-controlled, multicenter, Phase III clinical trial with 2:1 randomization evaluating the efficacy and safety of single-agent SU011248, as compared to placebo, in patients with Imatinib Mesylate-resistant or intolerant malignant gastrointestinal stromal tumor (GIST). Patients randomized to the placebo arm (Arm B) will be offered the opportunity to receive open-label SU011248 treatment upon development of RECIST-defined disease progression, provided that patient crossover eligibility criteria are met. Safety labs, pharmacokinetic (PK) trough levels and soluble protein assessment will be drawn as part of the study.