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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 " 这将是一项单中心I期研究，将入组符合入选标准且不符合下列排除标准的患者。我们计划在晚期实体瘤患者中研究PTK 787联合紫杉醇。 本研究的主要目的如下： " 评价递增剂量紫杉醇联合PTK 787的安全性和耐受性。 " 评价PTK 787和紫杉醇单独给药和联合给药在本研究癌症患者中的药代动力学 " 通过使用C11一氧化碳PET扫描联合治疗引起的放射学变化评价PTK 787和紫杉醇的药效学活性，以评价治疗期间的肿瘤血流变化 患者将按顺序入组6个队列中的1个，每个队列将由3 - 6例患者组成。将评估6个剂量水平。从D-11开始，PTK 787的剂量水平为250、500、750、1000和1250 mg，每天口服给药。紫杉醇的剂量水平为75、85、100 mg/m2 IV，每28天在第1、8和15天给药一次。 在入组下一个队列之前，将在整个28天治疗周期内对队列中的所有患者进行安全性评价。本研究将包括筛选期和基线期、导入期、治疗期（包括28天研究药物给药）。 PTK 787将持续使用，直至出现显著的治疗相关毒性或疾病进展。 如果毒性允许，将继续使用紫杉醇，直至进展，最多6个周期。 本研究的评估如下： " 治疗后出现的不良事件，包括实验室评估和定向神经系统 " 考试 " 肿瘤测量和肿瘤标志物测量（如适用） " 全血样本的药代动力学评估