NCT02209701终止1 期
A Phase I Intensive Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors Who Receive Radiation Therapy
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
- 主要终点
- Amount of analyte excreted in urine
研究概览
简要总结
Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin and major metabolites in head and neck cancer and other cancer patients with solid tumors who receive radiation therapy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven advanced head and neck cancer or other solid tumors undergoing radiation therapy
- •Patients with prior chemotherapy will be considered if chemotherapy occurred more than 30 days prior to this study
- •Patients must be receiving concomitant radiotherapy (RT)
- •Performance status of ≥ 70% on the Karnofsky performance scale (KPS)
- •Must be ≥ 18 years of age
- •Expected survival of at least three months
- •Written informed consent
排除标准
- •Patients who meet any of the following clinical laboratory criteria:
- •Granulocyte count of < 2000/mm**3
- •Platelets < 75,000/mm**3
- •Serum creatinine > 1.5 times the upper limit of normal
- •Bilirubin > 1.5 times the upper limit of normal
- •Prothrombin time and partial thromboplastin time > 1.5 times the upper limit of normal
- •Women who are pregnant
- •Men and women of child-bearing potential who are unwilling to utilize a medically acceptable method of contraception
- •Patients who have any known bleeding disorder at the discretion of the investigator
- •Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependent chronic obstructive pulmonary disease, or unstable liver or renal disease
- •Treatment with granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor or Interleukin-1l within 30 days prior to the start of RT
- •Patients who have had prior exposure to mitomycin C or porfiromycin
研究组 & 干预措施
Porfiromycin
Experimental
干预措施: Porfiromycin (Drug)
结局指标
主要结局
Amount of analyte excreted in urine
时间窗: 0-3 and 3-6 hours after infustion
Assessment of serum concentrations of the analyte
时间窗: up to 6 hours after drug infusion
次要结局
未报告次要终点
研究者
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