A Phase I, Open Label, Dose Escalation Study of a New Formulation of Calcitriol (DN-101) for Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novacea
- 入组人数
- 60
- 试验地点
- 4
研究概览
简要总结
The purposes of this study are to:
- Test the safety of DN-101 in patients with advanced malignancies
- Understand how fast the body absorbs, processes, and eliminates DN-101
- Determine the highest dose of DN-101 that is well tolerated by cancer patients
- Learn how fast the body absorbs, processes, and eliminates DN-101 compared to the approved product
详细描述
Calcitriol, at low doses, is approved by the FDA for use in patients with chronic renal failure. However, much higher doses of calcitriol are needed for any possible anti-cancer effect. DN-101 is a new capsule that contains 30 times the amount of calcitriol found in the currently available calcitriol capsule. In order to take an amount of calcitriol equivalent to 1 capsule of DN-101, cancer patients would need to swallow 30 pills of the approved, low dose formulation.
DN-101 is a pill containing calcitriol, a chemical related to vitamin D that is immediately active in your body. The natural vitamin D found in dairy products or in typical vitamin pills, must be chemically changed by your liver and kidney into calcitriol before it is active. High doses of calcitriol had anti-cancer effects when tested in animals. DN-101 may have anticancer effects in your kind of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- •Patients with advanced solid tumor malignancies
- •Patients with prostate cancer are eligible 1) if they have had a prostatectomy or radiation therapy and have a rising PSA, 2) if they have androgen sensitive prostate cancer and are on hormone therapy, or 3) if they have androgen independent prostate cancer and have failed hormone therapy
- •Patients with other types of malignancies will be required to have failed at least one potentially effective therapy prior to study entry
- •Life expectancy > 3 months
- •Age > 18 years
- •The following laboratory results:
- •Adequate hematologic function
- •Adequate renal function
- •Adequate liver function
- •Negative urine pregnancy test (females of childbearing potential only)
- •Willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment
- •Signed informed consent form
排除标准
- •Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
- •Significant active medical illness (other than current cancer) which in the opinion of the investigator would preclude protocol treatment
- •History of cancer-related hypercalcemia, known hypercalcemia, or vitamin D toxicity
- •Uncontrolled heart failure
- •Kidney stones (calcium salt) within the past 5 years
- •Prior investigational therapy within the past 30 days
- •Prior use of calcitriol within the past 3 months or known hypersensitivity to calcitriol
- •Concurrent active treatment for cancer with the exception of treatment for androgen-independent prostate cancer
- •Excluded concomitant medications: calcium- or magnesium-containing antacids, bile-resin binders, bisphosphonates, or calcium supplements; ketoconazole or related compounds