NCT03300921终止1 期
A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) on pancreatic tumors in patients who are planned for surgical removal of their tumor. The study will also look at the safety of paricalcitol prior to surgery.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration.
- •Age greater than or equal to 18 years
- •Medically fit for surgery in the opinion of the treating surgeon
- •Ability to provide written informed consent
排除标准
- •Patients who are currently pregnant, planning to become pregnant, or breast-feeding.
- •Note: women of childbearing potential must agree to use a medically accepted form of birth control including (condoms, diaphragms, cervical cap, an intra-uterine device (IUD), surgical sterility [tubal ligation or a partner that has undergone a vasectomy], or oral contraceptives). OR must agree to completely abstain from intercourse for two weeks before beginning study treatment, during participation in this study, and for 2 weeks after the final study treatment
- •Patients with hypercalcemia (blood levels greater than 11.5 mg/dL). Note: In patients with GFR 30-60 mL/min by Cockroft-Gault, blood calcium levels must be 9.5 mg/dL or lower before starting paricalcitol.
- •Serum creatinine > 2.5 x ULN OR GFR <30 mL/min by Cockroft-Gault formula . Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation.
研究组 & 干预措施
Arm A
Experimental
Arm A: 50mcg IV weekly
干预措施: Paricalcitol (Drug)
Arm B
Experimental
Arm B: 12mcg PO daily
干预措施: Paricalcitol (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 18 months
次要结局
未报告次要终点
研究者
研究点 (1)
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