Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle
研究概览
简要总结
This is an open label, dose escalation study to determine the safety and tolerability and maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors.
详细描述
This is an open label, dose escalation study to determine the maximum tolerated dose (MTD) of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors. There will be a dose expansion cohort of thirty patients to assess detailed pharmacokinetics and to assess any signal of activity in patients with solid tumors and in a portion who have breast cancer that is triple negative (ER-negative, PR-negative, and HER2-negative).
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
- •Confirmed diagnosis of a solid malignancy with advanced disease that has relapsed, that is refractory to standard therapies, or for which there is not standard therapy, or for which the patient opts not to receive standard therapy.
- •At the recommended phase II dose level, triple-negative breast cancer defined as ER-negative, PR-negative, and HER2-negative, will be enrolled and another 10 patients with a solid malignancy who would benefit from a paclitaxel and carboplatin-based regimen, will also be enrolled.
- •Male or female ≥ 18 years of age
- •Able to swallow and retain oral medications
排除标准
- •Major surgery within last 28 days or cytotoxic chemotherapy, biologic therapy, investigational agents, or radiotherapy within last 21 days. Patients who have completed therapy with mitomycin C or nitrosurea will have to wait 42 days.
- •More than 3 prior lines of cytotoxic chemotherapy for metastatic disease
研究组 & 干预措施
Pazopanib with paclitaxel and carboplatin
干预措施: Pazopanib (Drug)
Pazopanib with paclitaxel and carboplatin
干预措施: Paclitaxel (Drug)
Pazopanib with paclitaxel and carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle
时间窗: 4 years, 6 months
Toxicity will be assessed every 28 days up to 30 days after the last dose of treatment. Dose limiting toxicity is defined as 1. Non-hematological toxicity ≥ grade 3 (excluding alopecia, nausea, vomiting, or diarrhea for which adequate supportive therapy has not been instituted). 2. Hematologic toxicity: * Grade 4 neutropenia lasting ≥ 7 days * Grade 4 neutropenia and fever of ≥ 38.5°C * ≥ Grade 3 neutropenia with ≥ Grade 3 infection * Grade 4 thrombocytopenia * Inability to start next cycle of treatment by more than 4 weeks due to unresolved toxicity
次要结局
- Determine the drug-drug interactions with paclitaxel, carboplatin, and pazopanib(4 years, 3 months)
研究者
Nancy Chan, MD
Assistant Professor of Medicine
Rutgers, The State University of New Jersey