CLINICAL TRIAL: PHASE 2: CCI-779 IN COMBINATION WITH BEVACIZUMAB IN STAGE III OR

临床试验：第 2 阶段：CCI-779 与贝伐珠单抗组合处于第 III 阶段或

• 批准号: 7951485
• 负责人: Craig Lee Slingluff
• 金额: $ 15.01万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951485
• 关键词: Biological Markers; CCI-779; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Evaluation; Funding; Goals; Grant; Institution; Investigation; Molecular Target; Monitor; National Cancer Institute; Outcome; Participant; Patients; Phase; Phase II Clinical Trials; Research; Research Personnel; Resources; Safety; Schedule; Series; Site; Source; Specific qualifier value; Staging; United States National Institutes of Health; bevacizumab; design; melanoma

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 multi site phase II evaluation of bevacizumab plus CCI-779, in participants with stage III or IV melanoma. Up to 23 participants will receive study treatment. The primary goal is to ascertain whether treatment with bevacizumab plus CCI-779 at the specified doses and schedule can produce sufficient clinical activity against melanoma to warrant further investigation. Treatment will consist of 26 cycles. Each cycle is 14 days. CCI-779 will be administered on days 1 and 8 of cycles 1-26. Bevacizumab will be administered on day 8 of cycles 1-26. Safety information will be monitored monthly on all participants throughout the study. A 2-staged design will be used to determine if accrual should be halted due to insufficient antitumor activity. This study is one of a series of National Cancer Institute sponsored studies participating in the Molecular Targeted Combinations Correlative (MTC2) Study Initiative to evaluate possible biomarkers that correlate with patient outcomes to treatment with targeted agents.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是对III期或IV期黑色素瘤的参与者的Bevacizumab Plus CCI-779的多个位点II期评估。 多达23名参与者将接受学习治疗。 主要目的是确定贝伐单抗加上CCI-779的治疗是否以指定剂量和时间表可以产生针对黑色素瘤的足够的临床活动，以保证进一步研究。 治疗将由26个周期组成。 每个周期是14天。 CCI-779将在周期1-26的第1天和第8天进行管理。 贝伐单抗将在周期1-26的第8天进行管理。 在整个研究中，将对所有参与者每月监控安全信息。由于抗肿瘤活性不足，将使用2阶段的设计来确定应计算是否应停止。 这项研究是参与分子靶向组合相关性（MTC2）研究计划的一系列国家癌症研究所之一，旨在评估与患者结局相关的可能的生物标志物与靶向药物治疗相关的生物标志物。