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: 7717530
• 负责人: CHRISTOPHER J SWEENEY
• 金额: $ 0.1万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717530
• 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

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 “这将是一项单中心 I 期研究，将纳入符合纳入标准且不表现出下列排除标准的患者。我们计划在晚期实体瘤患者中研究 PTK787 加紫杉醇。 本研究的主要目标如下： “评估紫杉醇与 PTK787 联合用药剂量递增的安全性和耐受性。 " 评估本研究中癌症患者单独使用 PTK787 和紫杉醇以及联合使用的药代动力学 " 通过组合引起的放射学变化评估 PTK787 和紫杉醇的药效活性，利用 C11 一氧化碳 PET 扫描评估治疗时肿瘤血流的变化 患者将按顺序入组 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 的剂量水平将为每天口服 250、500、750、1000 和 1250 mg。紫杉醇的剂量水平为每 28 天在第 1、8 和 15 天静脉注射 75、85,100 mg/m2。 在纳入下一个队列之前，将在整个 28 天的治疗周期中对队列中的所有患者进行安全性评估。该研究将包括筛选和基线期、磨合期、治疗期（包括 28 天的研究药物给药）。 PTK787将持续使用，直到出现显着的治疗相关毒性或疾病进展。 紫杉醇将继续使用，直至出现毒性允许的进展，最多 6 个周期。 本研究的评估如下： “治疗突发不良事件，包括实验室评估和定向神经学评估 ” 考试 " 肿瘤测量和肿瘤标志物测量（如果适用） " 全血样本的药代动力学评估