A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and to establish what happens to the drug once inside the body. An escalating dose of PG-11047 will be investigated in this study and the maximum tolerated dose of the drug will be established.
详细描述
This is an open-label phase I, dose-escalation safety study in subjects with refractory solid tumors. The primary objectives of the study are to assess the safety, tolerability, and pharmacokinetics of PG-11047. PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. The planned minimum treatment schedule is 2 cycles (8 weeks) of PG-11047 treatment. Subjects who tolerate treatment may be eligible to receive additional cycles as per investigator's medical judgment. Evaluation of anti-tumor response will be performed every 2 cycles.
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
- •non-hematological malignancy where standard therapeutic measures do not exist or no longer effective.
- •ECOG - 0-
- •Life expectancy > 3 months.
排除标准
- •chemotherapy or radiotherapy within 4 weeks prior to entering the study.
- •previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell transplantation.
- •primary brain tumors or active brain metastases
- •history of significant or symptomatic cardiac arrhythmia, prior myocardial infarction or evidence of a current significant ventricular conduction abnormality
研究组 & 干预措施
PG-11047
干预措施: PG-11047 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: The MTD had to occur during cycle 1 of treatment
The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT). Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047.
次要结局
- Preliminary Efficacy(For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate.)