IMATINIB MESYLATE-RESISTANT OR INTOLERANT MALIGNANT GASTROINTESTINAL TUMOR

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项双臂、双盲、安慰剂对照、多中心、2:1随机分组的III期临床试验，评估单药SU011248与安慰剂相比，在耐伊马替尼甲磺酸耐药或不耐受的恶性胃肠道间质瘤（GIST）患者中的疗效和安全性。随机分配到安慰剂组（B组）的患者在出现recist定义的疾病进展时，只要符合患者交叉资格标准，将有机会接受开放标签SU011248治疗。安全性实验室、药代动力学（PK）低谷水平和可溶性蛋白评估将作为研究的一部分。

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.