NCT00731861已完成1 期
Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of escalating doses of paclitaxel in combination with PTK787
研究概览
简要总结
This study will evaluate PTK787, a new oral drug that stops blood vessel development, in combination with Paclitaxel in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with histologically confirmed malignancy that is unresponsive to curative therapy and for which no conventional therapy exists
- •ECOG Performance Status 0-2
- •Measurable or evaluable disease
- •Laboratory values within protocol limits within 2 weeks prior to registration
- •Life expectancy ≥ 12 weeks
- •Patient or guardian must have written informed consent obtained according to local guidelines
- •Women of child-bearing potential (non-sterile) must use appropriate barrier contraception for duration of study (negative pregnancy test required at baseline). Oral contraceptives will not be an acceptable form of contraception
- •Patients may have received prior standard taxane therapy, but have never progressed on taxane-based therapy.
排除标准
- •History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
- •Prior chemotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
- •Prior biologic or immunotherapy ≤ 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
- •Prior full pelvic field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization.
- •Major surgery (i.e., laparotomy) ≤ 4 weeks prior to randomization. Minor surgery ≤ 2 weeks prior to randomization.
- •Patients who have received investigational drugs ≤ 4 weeks prior to registration
- •Prior therapy with anti-VEGF agents
- •Peripheral neuropathy with functional impairment ≥ CTC grade 2 neuropathy, regardless of causality
- •Pleural effusion or ascites that causes respiratory compromise (≥ CTC grade 2 dyspnea)
- •Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
- •Patient agrees to avoid grapefruit (juice and fruit)
- •Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- •Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
- •Unstable angina pectoris
- •Congestive heart failure greater than NYHA classification ≥ Grade 1 (can be controlled with medication)
- •Myocardial infarction ≤ 6 months prior to registration and/or randomization
- •Serious uncontrolled cardiac arrhythmia
- •Uncontrolled diabetes at discretion of investigator
- •Active or uncontrolled infection requiring intravenous antibiotics
- •Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- •Patients at risk of QT prolongation such as patients with congenital long QT syndrome or with long QTc at baseline (i.e. QTc greater than 450 msec in males, and greater than 470 msec in females) will be excluded
研究组 & 干预措施
1
Experimental
Paclitaxel plus PTK787
干预措施: Paclitaxel plus PTK787 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of escalating doses of paclitaxel in combination with PTK787
时间窗: Baseline through End of Study
次要结局
- To evaluate the pharmacokinetics of paclitaxel alone and in combination with PTK787 from patients with cancer accrued to this study(Baseline through End of Study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate CancerProstate CancerNCT00134355University of Michigan Rogel Cancer Center5
已完成
1 期
PTK787/ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic DrugsGlioblastomaNCT00385853Massachusetts General Hospital19
已完成
1 期
PTK787/ZK222584 With Bevacizumab in Patients With Refractory and/or Advanced MalignanciesRefractory MalignancyAdvanced MalignanciesNCT00611793SCRI Development Innovations, LLC50
终止
1 期
Trial of PTK787/ZK 222584 Plus PaclitaxelMetastatic Non-hematologic MalignanciesNCT00358163Dana-Farber Cancer Institute7
已完成
1 期
RDEA3170 and Febuxostat Drug Interaction StudyHealthyNCT01883167Ardea Biosciences, Inc.21