Assessment of the Effects of the Specific Endothelin-A Antagonist ZD4054 on Prostate Cancer Biomarkers in Patients With Castrate-resistant Metastatic Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in tissue biomarkers
研究概览
简要总结
This is a prospective study in which patients with castrate-resistant prostate cancer and bone metastases will undergo imaging, donate blood, bone marrow and urine samples, and where possible primary tumour and bone metastatic tissue, before and during treatment with ZD4054, an orally active specific endothelin-A antagonist. The samples will be used primarily for biomarker studies, and it is hypothesized that these will inform on the mechanism of action of this drug. Magnetic Resonance Imaging (MRI) will be performed to evaluate emerging functional imaging endpoints as markers of early response in bone metastatic prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •histological confirmation of prostate adenocarcinoma
- •documented evidence of bone metastasis on bone scan or MRI
- •biochemical progression of prostate cancer
- •surgically or medically castrate with serum testosterone ≤2.4nmol/L
- •ECOG performance status 0 - 2
- •life expectancy of 6 months or more.
排除标准
- •radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment.
- •prior targeted cancer therapies (such as gefitinib, bevacizumab)
- •systemic radionuclide therapy within 12 weeks of starting study treatment.
- •current therapy, within 4 weeks of study entry with potent inhibitors of CYP3A4 (ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of CYPs 2D6 and 2C9 (quinidine and fluconazole), and potent P450 inducers (phenytoin, rifampicin, carbamazepine and phenobarbitone)
- •definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists
- •ineligibility for MRI scanning includes standard MRI criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based MRI contrast agents
结局指标
主要结局
Changes in tissue biomarkers
时间窗: 6 weeks
Changes in blood-borne biomarkers
时间窗: 12 weeks
Changes in imaging biomarkers
时间窗: 12 weeks
次要结局
未报告次要终点