A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Clinical Benefit Rate From Cabozantinib (XL184)
研究概览
简要总结
This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant prostate cancer.
详细描述
Cabozantinib (XL184), a multi-targeted tyrosine kinase inhibitor, has demonstrated a powerful clinical phenotype in men with metastatic castrate resistant prostate cancer (mCRPC) both before and after chemotherapy. This phenotype consists of rapid reduction in pain (when present) and improvement in bone scans that may or may not be accompanied by decrease in serum prostate specific antigen (PSA) concentrations. In previous studies of cabozantinib in advanced prostate cancer, patients with visceral disease have been excluded. Hence, this protocol creates a unique opportunity to define the activity of this disease in the population of men with visceral disease - a marker for poorer prognosis in mCRPC.
Primary Objectives:
- To assess the clinical benefit (complete response + partial response + stable disease) of cabozantinib in patients with mCRPC with visceral metastases.
Secondary Objectives:
- To assess the impact of cabozantinib on numbers live circulating tumor cells (CTCs) using NanoVelcro Chips
- To test the feasibility of measuring variation in gene expression in circulating tumor cells (CTCs) in response to therapy.
- To determine if there is an impact of cabozantinib on live circulating tumor cell (CTC) number and patterns of gene expression.
- To measure the impact of cabozantinib on serum HGF (hepatocyte growth factor) and VEGF (vascular endothelial growth factor) levels in men with metastatic, castration-resistant prostate cancer (mCRPC).
- To assess the safety and tolerability of lower doses (i.e. doses below 100 mg daily) of cabozantinib in mCRPC with visceral involvement.
- To collect blood, urine, tissue, and plasma which may be used determine if there are germline genetic variations that correlate with toxicity.
- To pilot correlations between molecular content between circulating tumor cells (CTCs), large oncosomes, and tumor tissue.
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
- 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
Treatment (cabozantinib)
Cabozantinib 60mg orally daily until disease progression
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Clinical Benefit Rate From Cabozantinib (XL184)
时间窗: Baseline to 12 weeks after starting therapy
Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria. Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) \>=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease.
次要结局
- Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib(Baseline and 12 weeks)
- Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells(12 weeks)
- Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration(12 weeks)
- Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4)(Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks.)
- Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death(From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks.)
研究者
Edwin Posadas, MD
Medical Director, Urologic Oncology Program
Cedars-Sinai Medical Center