PHASE I, PHARMACOKINETIC, PHARMACODYNAMIC TRIAL OF PTK787 AND PACLITAXEL IN C

PTK787 和紫杉醇在 C 中的 I 期药代动力学、药效学试验

• 批准号: 7606433
• 负责人: CHRISTOPHER J SWEENEY
• 金额: $ 1.18万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606433
• 关键词: Adverse event; Appearance; Blood flow; Blood specimen; Carbon Monoxide; Computer Retrieval of Information on Scientific Projects Database; Disease Progression; Dose; Drug Kinetics; Enrollment; Exclusion Criteria; Exhibits; Funding; Grant; Institution; Laboratories; Malignant Neoplasms; Measurement; Neurologic Examination; PTK787; Paclitaxel; Patients; Pharmaceutical Preparations; Pharmacodynamics; Phase; Phase I Clinical Trials; Positron-Emission Tomography; Research; Research Personnel; Resources; Running; Safety; Screening procedure; Solid Neoplasm; Source; Toxic effect; Tumor Markers; United States National Institutes of Health; Whole Blood; cohort; day; inclusion criteria; treatment duration; 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. " This will be a single center Phase I study which will enter patients who meet the inclusion criteria and exhibit none of the exclusion criteria listed below. We plan on studying PTK787 plus paclitaxel in patients with advanced solid tumors. The primary objectives of this study are as follows: " To evaluate the safety and tolerability of escalating doses of paclitaxel in combination with PTK787. " To evaluate the pharmacokinetics of PTK787 and paclitaxel alone and in combination from patients with cancer accrued to this study " To evaluate the pharmacodynamic activity of PTK787 and paclitaxel via radiographic changes caused by the combination utilizing C11 Carbon Monoxide PET scanning to evaluate tumor blood flow changes with therapy Patients will be enrolled sequentially into 1 of 6 cohorts and each cohort will consist of 3 to 6 patients. Six dose levels will be assessed. The dose levels of PTK787 will be 250, 500, 750, 1000, and 1250 mg administered orally every day starting on D-11. The dose levels of Paclitaxel will be 75, 85,100 mg/m2 IV given on days 1, 8, and 15 every 28 days. All patients in a cohort will be evaluated for safety throughout the 28-day treatment cycle prior to enrollment of the next cohort. The study will consist of a Screening and Baseline Period, Run-in Period, Treatment Period consisting of 28 days of study drug administration. PTK787 will continue until the appearance of significant treatment-related toxicities or disease progression. Paclitaxel will be continued until progression as toxicity permits with a maximum of 6 cycles. The assessments for this study are as follows: " Treatment emergent adverse events including laboratory assessments and directed neurological " Examinations " Tumor measurements and measurements of tumor markers (if appropriate) " Pharmacokinetic assessments from whole blood sample

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。 这将是一项单中心第一阶段研究，将进入符合纳入标准的患者，并且没有表现出以下列出的排除标准。我们计划研究PTK787加紫杉醇治疗晚期实体肿瘤患者。 这项研究的主要目标如下： 以评估递增剂量紫杉醇与PTK787联合应用的安全性和耐受性。 “评估PTK787和紫杉醇单独和联合在本研究中累积的癌症患者中的药代动力学 用C11一氧化碳正电子发射计算机断层扫描评价PTK787和紫杉醇联合治疗后肿瘤血流变化的放射学变化 患者将按顺序纳入6个队列中的1个，每个队列由3至6名患者组成。将评估六个剂量水平。从D-11开始，PTK787的剂量水平将分别为250、500、750、1000和1250毫克。紫杉醇的剂量水平分别为75、85、100 mg/m2，静脉滴注，第1、8、15天，每28天一次。在纳入下一个队列之前，将在28天的治疗周期中对队列中的所有患者进行安全性评估。这项研究将包括筛查和基准期、磨合期和治疗期，其中包括28天的研究用药。PTK787将一直持续到出现与治疗相关的重大毒性或疾病进展。紫杉醇将在毒性允许的情况下继续使用，直到进展，最多6个周期。 这项研究的评估如下： “治疗突发不良事件，包括实验室评估和定向神经学 “考试 “肿瘤测量和肿瘤标记物的测量(如果适用) “全血样本的药代动力学研究