NCT01608009已完成1 期
Phase 1b Exploratory Study of [18F]Fluciclatide-PET as a Marker of Angiogenic Response to Combination Therapy With the Pan-VEGF Inhibitor, Pazopanib, and Weekly Paclitaxel in Platinum Resistant Ovarian Cancer
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
- 16
- 试验地点
- 2
- 主要终点
- Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment
研究概览
简要总结
The purpose of this study is to assess [18F] -fluciclatide as a biomarker of response to pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel in platinum-resistant ovarian cancer patients.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of relapsed ovarian cancer
- •Responded to at least on one line of prior platinum based therapy
- •Relapsed within platinum resistant interval (≤6months)
- •Eastern Cooperative Oncology Group (ECOG) performance status of <2
- •Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques
- •Satisfactory baseline haematologic and organ function:
- •Haematologic: Absolute neutrophil count > or = 1.5 X 10^9/L; Platelets > or = 100 X 10^9/L; Haemoglobin > or = 9g/dL; PT or INR < or = 1.2 x ULN; PTT < or = 1.2 x ULN
- •Hepatic: Bilirubin < or = 1.5 X ULN; AST or ALT < or = 2.5 X ULN
- •Renal: Serum creatinine < or = 1.5 mg/dL; Or if >1.5 mg/dL, calculated creatinine clearance > or = 50mL/min; UPC <1
排除标准
- •Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study.
- •Treatment with any of the following anti-cancer therapies:
- •radiation therapy 28 days prior to the first dose of pazopanib OR
- •surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
- •chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
- •Treatment with anti-angiogenic therapy
- •Presence of gross ascites
- •Clinically significant peripheral neuropathy
- •Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study
研究组 & 干预措施
Pazopanib and paclitaxel
Experimental
干预措施: Pazopanib and paclitaxel (Drug)
结局指标
主要结局
Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment
时间窗: 1 week
Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant
次要结局
- The proportion of women who experience side effects from the combination of paclitaxel and pazopanib(12 months)
- The proportion of patients responding to combination paclitaxel and pazopanib(12 months)
研究者
研究点 (2)
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