IMATINIB MESYLATE-RESISTANT OR INTOLERANT MALIGNANT GASTROINTESTINAL TUMOR

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项2：1随机化的双组、双盲、安慰剂对照、多中心、III期临床试验，旨在评价SU 011248单药治疗甲磺酸伊马替尼耐药或不耐受的恶性胃肠道间质瘤（GIST）患者与安慰剂相比的疗效和安全性。随机分配至安慰剂组（B组）的患者在发生RECIST定义的疾病进展后，将有机会接受开放标签SU 011248治疗，前提是符合患者交叉合格性标准。 作为研究的一部分，将进行安全性实验室检查、药代动力学（PK）谷水平和可溶性蛋白评估。

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.