A Phase II, Open-label, Multicentre Study of PM060184 in Patients With Advanced Colorectal Cancer After Standard Treatment.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Progression-free Survival Rate at Three Months
研究概览
简要总结
This trial will evaluate the efficacy of PM060184 in terms of progression-free survival at 12 weeks (PFS3) in advanced or metastatic Colorectal Cancer (CRC) patients with any KRAS mutation status (wild- type; mutated; or unknown status) progressing after standard treatments (fluoropyrimidine, irinotecan, and oxaliplatin).
Patients in this trial will receive PM060184 at a dose of 9.3 mg/m2 as a 30-minute intravenous (i.v.) infusion on Days 1 and 8 q3wk.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PM060184
PM060184
干预措施: PM060184 (Drug)
结局指标
主要结局
Progression-free Survival Rate at Three Months
时间窗: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 3 months
Progression-free survival rate at 12 weeks (PFS3), defined as the rate estimate of the percentage of patients who are alive and progression-free at 12 weeks (\~3 months) after the first treatment administration. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
- Overall Survival (OS)(From the first day of treatment to the date of death or last contact, up to 12 months)
- Progression Free Survival (PFS)(Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months)
- Overall Response Rate (ORR)(Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months)