A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 18
- 主要终点
- Response Rate (Complete or Partial)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well PR-104 works in treating patients with previously untreated or relapsed small cell lung cancer (SCLC).
详细描述
OBJECTIVES:
Primary
- Estimate the response rate of PR-104 in patients with treatment-naive or sensitive-relapse small cell lung cancer.
- Evaluate safety of this drug in these patients. Secondary
- Evaluate survival of these patients.
- Evaluate progression-free survival of these patients.
- Evaluate time to progression in these patients.
- Assess the pharmacokinetics (PK) of PR-104 and its alcohol metabolite.
- Estimate the rate of hypoxia using 18F-fluoromisonidazole (FMISO) positron emission topography (PET) imaging.
- Collect plasma samples for assessment of potential biomarkers of tumor hypoxia.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type (treatment-naive vs sensitive-relapse).
Patients receive PR-104 intravenously (IV) over 1 hour on day 1. Treatment repeats every 21 days for up to 4 courses (for treatment-naive patients) or in the absence of disease progression or unacceptable toxicity (for sensitive-relapse patients).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PR104
PR104 will be administered once every 21 days by IV
干预措施: PR104 (Drug)
PR104
PR104 will be administered once every 21 days by IV
干预措施: F-18-fluoromisonidazole (Other)
结局指标
主要结局
Response Rate (Complete or Partial)
时间窗: From registration until disease progression/recurrence
Safety and Tolerability: the Number of Subjects Experiencing a Serious Adverse Events
时间窗: 30 days following the last administration of study treatment
The number of participants with at least one Serious Adverse Event was measured.
次要结局
- Survival(Every 3 months for 2 years after discontinuation)
- Progression-free Survival(Tumor measurements and assessments based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria were performed 6 weeks after first dose and as dictated by subject's malignancy)
- Time to Progression(From registration of the first subject until radiological progression or recurrence whichever came first)
- Pharmacokinetics(Days 1 and 2 of Cycles 1 and 4)