A Phase I, Dose-escalation Study of a Combination AS703569 and Gemcitabine Given to Subjects With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
In clinical practice and research, combination of anticancer agents is often used to improve efficacy of treatment. In vitro and in vivo experiments have shown additive-synergistic anti-tumour effects of AS703569 treatment when combined with gemcitabine. Specifically, additive-synergistic anti-tumour effects were noticed when the two agents were given sequentially and not concomitantly i.e. AS703569 given the day before or the day after gemcitabine. This trial was designed to investigate in parallel two regimens testing sequential administration of AS703569 either the day after gemcitabine infusion, (Regimen 1) or the day before (Regimen 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically/cytologically confirmed diagnosis of measurable or assessable malignancy, who meets one of the following conditions:
- •Subject with a tumour for which gemcitabine is approved, Subject with a tumour for which gemcitabine is considered standard of care, Subject with other tumour type either refractory or intolerant to or for whom there is not an accepted standard treatment.
- •Male or female with at least 18 years of age. Life expectancy of at least 3 months.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status <
- •No more than 3 prior chemotherapy regimens for advanced/metastatic disease.
- •At least 4 weeks since last chemotherapy, hormonal therapy, immunotherapy, biological or any other pharmacological or investigational treatment or radiotherapy (6 weeks wash-out for nitrosoureas and mitomycin C, 5 half-lives for non-cytotoxics). Subjects on chronic hormonal therapy may continue with the same treatment unchanged.
- •Adequate renal, hepatic and bone marrow functions (assessed 7 days before inclusion in the trial) as defined by:
- •Serum creatinine
排除标准
- 未提供
研究组 & 干预措施
Regimen 1: AS703569/gemcitabine
Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle
干预措施: AS703569/gemcitabine (Drug)
Regimen 2: AS703569/gemcitabine
AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle
干预措施: AS703569/gemcitabine (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: 21 days
To determine the maximum tolerated dose (MTD) during a 21-day cycle, for each of the two planned regimens using combination therapy with AS703569 and gemcitabine.
次要结局
- Progression-Free Survival (PFS) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)(Variable)
- Progressive disease (PD)(Every other cycle)
- Treatment-emergent adverse events (TEAE)(Minimum 21 days or 1 cycle)
- Best overall response (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)(Every other cycle)
- Overall Survival (OS) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)(Variable)
- Time to Tumor Progression (TTP) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)(Variable)