CPTK787/ZK222584 IN PATIENTS WITH METASTATIC NEUROENDOCRINE TUMORS

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。这是一项开放标签、II期研究，旨在评价PTK 787/ZK 222584每日一次给药在正在发生疾病进展和/或尽管接受了最佳剂量的奥曲肽治疗但肿瘤相关综合征症状（潮红和腹泻）控制不佳的神经内分泌肿瘤受试者中的安全性和疗效。控制不佳定义为连续7天每天至少2次潮红发作或6次排便。符合所有入选和排除标准且已完成所有基线和筛选检查的受试者将接受PTK 787/ZK 222584 1，250 mg每日一次的初始剂量，受试者还将继续接受预定剂量的Sandostatin LAR 30 mg每4周一次。这两种药物将按照mg的统一时间表给药，而不是按照体重或体表面积给药。PTK 787/ZK 222584药物将每日口服给药。每片PTK 787/ZK 222584为250 mg。受试者每天将服用5片研究药物。只要受试者未出现不可接受的毒性或实体瘤疗效评价标准（RECIST）定义的疾病进展证据，则可继续接受治疗。将使用每日日志对受试者进行评价，以评估症状控制程度（潮红和腹泻），并将每月监测受试者的生化控制，每三个月监测一次肿瘤缓解。

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 an open-label, phase II study evaluating the safety and efficacy of PTK787/ZK222584 administered daily in subjects with neuroendocrine tumors that are experiencing progressive disease and/or whose tumor-related syndrome symptoms (flushing and diarrhea) are considered inadequately controlled despite optimal doses of octreotide therapy. Inadequate control is defined as a minimum of 2 flushing episodes or 6 bowel movements per day for 7 consecutive days. Subjects who meet all inclusion and exclusion criteria and have completed all baseline and screening testing will receive an initial dose of PTK787/ZK222584 1,250 mg once daily and subjects will also remain on the scheduled doses of Sandostatin LAR 30 mg every 4 weeks. Both drugs will be dosed on a flat schedule of mg not by weight or body surface area. The PTK787/ZK222584 medication will be taken orally with daily dosing. Each tablet of PTK787/ZK222584 is 250 mg. The subject will take five tablets of study medication per day. Subjects may continue to receive therapy as long as they do not experience unacceptable toxicities or evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Subjects will be evaluated with a daily log to assess the degree of symptom control (flushing and diarrhea) and subjects will be monitored monthly for biochemical control and every three months for tumor response.