A Phase I/II, Open-Label, Multicenter, Two-Arm, Feasibility Study of Pazopanib, Carboplatin, and Paclitaxel in Women With Newly Diagnosed, Previously Untreated, Gynaecological Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events
研究概览
简要总结
This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled. Dose schemas for each study arm are described in the protocol. For each arm, six subjects will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen 125 (CA-125) responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Oral Pazopanib 800 mg once a day+ carboplatin area under the concentration-time curve (AUC) 5 intravenous (IV) over 1 hour every 3 weeks + paclitaxel 175 mg/m^2 IV over three hours day one q 3 weeks for six cycles
干预措施: pazopanib (GW786034) (Drug)
Arm A
Oral Pazopanib 800 mg once a day+ carboplatin area under the concentration-time curve (AUC) 5 intravenous (IV) over 1 hour every 3 weeks + paclitaxel 175 mg/m^2 IV over three hours day one q 3 weeks for six cycles
干预措施: carboplatin (Drug)
Arm A
Oral Pazopanib 800 mg once a day+ carboplatin area under the concentration-time curve (AUC) 5 intravenous (IV) over 1 hour every 3 weeks + paclitaxel 175 mg/m^2 IV over three hours day one q 3 weeks for six cycles
干预措施: paclitaxel (Drug)
Arm B
Oral Pazopanib 800 mg once a day+ carboplatin AUC 6 IV over 1 hour every 3 weeks + paclitaxel 175 mg/m^2 IV over three hours day one q 3 weeks for six cycles
干预措施: pazopanib (GW786034) (Drug)
Arm B
Oral Pazopanib 800 mg once a day+ carboplatin AUC 6 IV over 1 hour every 3 weeks + paclitaxel 175 mg/m^2 IV over three hours day one q 3 weeks for six cycles
干预措施: carboplatin (Drug)
Arm B
Oral Pazopanib 800 mg once a day+ carboplatin AUC 6 IV over 1 hour every 3 weeks + paclitaxel 175 mg/m^2 IV over three hours day one q 3 weeks for six cycles
干预措施: paclitaxel (Drug)
结局指标
主要结局
Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events
时间窗: Baseline to End of Study (up to a year)
Safety and tolerability were measured by the number of participants with serious adverse events and non-serious adverse events. See the "Adverse Event" section of the results record for additional details and data.
次要结局
- Overall Response(Baseline until either response or progression (up to 2 years))
- Cancer Antigen (CA-125) Response(Baseline until response (up to 2 years))
- 18-week Progression Free Survival(Baseline to Week 18)