Evalution of Safety, Tolerability and Pharmacokinetics of of HPPH in Ascending Dose for Cancer Patients in Phase I Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The number of dose-limiting toxicity
研究概览
简要总结
Phase I study was to investigate the safety and tolerability of the photosensitizer (PS) 2-[1-hexyloxyethyl]-2-devinyl pyropheophorbide-a (HPPH) for injection in patients with Esophageal Cancer. It was to characterize the pharmacokinetics of HPPH and efficacy of HPPH.
详细描述
The present study is phase I study to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending injection doses of HPPH in Patients with Esophageal Cancer. Up to 30 patients are planned to be enrolled in 6 cohorts with each cohort consisting of 3-6 patients ( male and/or female patients). In each cohort, patients will receive HPPH and Lyophilized treatment. The dose escalation in Cohorts was from 2.5 to 3, 3.5, 4, 5, and 6mg/m2 of HPPH, respectively, administered intravenous drop infusion over 1 hour, once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open
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
- •18 years of age or older, Male and female subjects with practicing a highly effective form of birth control, and a signed consent;
- •Subjects who was diagnosed as Esophageal Cancer or carcinoma of gastric cardia by endoscopy and Biopsy pathology at T1-T3 stage.
- •Subjects who could not be taken surgery or chemotherapy; with unsucessful surgery or failed chemotherapy; who had refused surgery and chemotherapy
- •ECOG 0-2, Life expectancy would be more than 3-month
排除标准
- •Subjects were diagnosed as Tracheoesophageal fistula or Esophageal mediatinal fistula, or more than 60 years old with having three kinds of Heart, Lung, Liver and Kidney commorbities;
- •Hematopoietic WBC < 3×109/L; HGB <80g/L; PLT <80×109/L; PLT <1.5 times upper limit of normal (ULN)
- •Hepatic TBIL>1.5ULN, ALT or AST >2.5 ULN
- •Alkaline phosphatase > 3 times ULN
- •Uncontrol Hypertension: Bp>160/100mmHg
- •Uncomtrol Diabetes
研究组 & 干预措施
HPPH 2.5 mg/m2
HPPH 2.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
干预措施: HPPH 2.5 mg/m2 (Drug)
HPPH 3 mg/m2
HPPH 3 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
干预措施: HPPH 3 mg/m2 (Drug)
HPPH 3.5 mg/m2
HPPH 3.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
干预措施: HPPH 3.5 mg/m2 (Drug)
HPPH 4 mg/m2
HPPH 4 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
干预措施: HPPH 4 mg/m2 (Drug)
HPPH 5 mg/m2
HPPH 5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
干预措施: HPPH 5 mg/m2 (Drug)
HPPH 6 mg/m2
HPPH 6 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
干预措施: HPPH 6 mg/m2 (Drug)
结局指标
主要结局
The number of dose-limiting toxicity
时间窗: Day 1 to Day 10
Dose-limiting toxicity would be assesed by CTCAE4.0
次要结局
- Apparent terminal elimination phase half (t1/2)(Day 1 to Day 84)
- Area under the concentration-time curve over the dosing interval (AUC0-t)(Day 1 to Day 84)
- Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞)(Day 1 to Day 84)
- Maximum observed concentration (Cmax)(Day 1 to Day 84)
- Time to maximum concentration (tmax)(Day 1 to Day 84)