A Pilot Study of the Effects of Cabozantinib (XL184) on Bone Turnover and the Microenvironment in Men With Non-Metastatic and Metastatic Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Urinary N-telopeptide (uNTX) as a Marker of Bone Metabolism in Non-metastatic Patients
研究概览
简要总结
This pilot clinical trial studies cabozantinib in treating men with castration-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
Primary Outcome Measure:
- Change in urinary N-telopeptide (uNTX) from baseline to after 6 weeks of treatment with cabozantinib in men with non-metastatic CRPC.
Secondary Outcome Measures: 2. Changes in serum markers of bone metabolism from baseline to after 6 weeks of treatment with cabozantinib. Markers of bone metabolism in blood include bone specific alkaline phosphatase, alkaline phosphatase, LDH. 3. Changes in biomarker expression in bone biopsy samples. To include MET, AKT, FASN and VEGFR2 expression and phosphorylation status (activation) in osteoblasts/osteoclasts and prostate cancer cells. Will also include changes in markers of apoptosis, proliferation, and angiogenesis.
OUTLINE:
Patients receive cabozantinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.
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
盲法说明
Treatment is open label and non-randomized. Split in to two patient populations - metastatic CRPC and non-metastatic CRPC.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 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
Cabozantinib in metastatic CRPC
Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.
干预措施: Cabozantinib (Drug)
Cabozantinib in non-metastatic CRPC
Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Change in Urinary N-telopeptide (uNTX) as a Marker of Bone Metabolism in Non-metastatic Patients
时间窗: Baseline and 6 weeks
Median percent change in Urinary N-Telopeptide from baseline compared to after 6 weeks of treatment with Cabozantinib in patients with non-metastatic prostate cancer.
次要结局
- Change in Alkaline Phosphatase as a Marker of Bone Metabolism(Baseline, 6 weeks)
- Change in Lactic Acid Dehydrogenase (LDH) as a Marker of Bone Metabolism(Baseline and at 6 weeks)
- Change in Bone Specific Alkaline Phosphatase as a Marker of Bone Metabolism(Baseline and at 6 weeks)
- Changes in Biomarker Expression in Bone Biopsy Samples(Baseline and at 6 weeks)
研究者
Celestia Higano
Principal Investigator
University of Washington