UAB 0540 - PHASE I STUDY OF CS-1008 FOR PATIENTS WITH ADVANCED TUMOR OR LYMPHOMA

UAB 0540 - CS-1008 针对晚期肿瘤或淋巴瘤患者的 I 期研究

• 批准号: 7603249
• 负责人: ANDRES FORERO
• 金额: $ 6.78万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603249
• 关键词: Computer Retrieval of Information on Scientific Projects Database; Dose; Dose-Limiting; Enrollment; Funding; Grant; In complete remission; Institution; Interruption; Investigational Drugs; Label; Lymphoma; Malignant Neoplasms; Numbers; Patients; Phase; Phase I Clinical Trials; Progressive Disease; Protocols documentation; Research; Research Personnel; Resources; Safety; Solid Neoplasm; Source; Toxic effect; United States National Institutes of Health; Week; cohort; intravenous administration; partial response; tumor

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. The primary objective of this study is to determine a recommended Phase II dose (RP2D) and document the safety profile for CS-1008, administered by weekly intravenous infusion to patients with advanced solid tumor or non-leukemic lymphomas. The protocol will be conducted as an open-label Phase I, dose-escalation study of CS-1008 in sequential cohorts of 3 to 6 patients with advanced solid tumor or lymphoma malignancies. A treatment cycle is arbitrarily defined as 3 weeks of once weekly treatment. Investigational drug will be administered weekly over two sequential 3-week cycles (i.e., 6 weeks), and will be continued without interruptions for up to 12 cycles in patients with complete response (CR) or partial response (PR), and for up to 4 cycles in patients with stable diseas(SD), in the absence of dose-limiting toxicity (DLT), as defined per protocol, or progressive disease (PD). Patients will be accrued in cohorts of three to six, beginning at dose level 1. Initiation of the next dose-level cohort will occur only after at least three patients in prior dose cohort have completed one cycle of treatment (3 weeks). Sixteen to 40 patients with advanced solid tumor or lymphoma malignancies are expected to be enrolled, depending on the number of dose escalations required to determine the recommended Phase II dose.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的主要目标是确定推荐的第二阶段剂量(RP2D)，并记录CS-1008的安全性，CS-1008每周静脉滴注给晚期实体瘤或非白血病淋巴瘤患者。 该方案将在3至6名晚期实体肿瘤或淋巴瘤恶性肿瘤患者的顺序队列中进行CS-1008的开放标签I期剂量递增研究。一个治疗周期被任意定义为每周一次的3周治疗。研究药物将在两个连续的3周周期(即6周)内每周给药，对于完全缓解(CR)或部分缓解(PR)的患者，将不间断地持续最多12个周期，对于稳定性疾病(SD)患者，在没有剂量限制毒性(DLT)的情况下，或在进展性疾病(PD)的情况下，将持续最多4个周期。从剂量水平1开始，患者将以3至6人为一组累积。 只有在前一个剂量队列中的至少三名患者完成一个疗程(3周)后，才会开始下一个剂量水平的队列。 预计将有16至40名患有晚期实体瘤或淋巴瘤恶性肿瘤的患者入选，这取决于确定推荐的第二阶段剂量所需的剂量递增次数。