An Open-label Pilot Study of the Effect of Second-line Treatment With Herceptin Monotherapy on Time to Disease Progression in Patients With Metastatic Urothelial Cancer and HER2 Overexpression
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 主要终点
- Percentage of Participants Progression Free at 12 and 24 Months
研究概览
简要总结
This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.
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
- •adult patients >=18 years of age;
- •metastatic urothelial cancer;
- •disease progression during or after 1 prior platinum-based chemotherapy;
- •measurable disease;
- •HER2 overexpression (IHC [2+] or [3+]).
排除标准
- •concomitant chemotherapy or immunotherapy;
- •active or uncontrolled infection;
- •solely CNS metastases;
- •clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
- •co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.
研究组 & 干预措施
Trastuzumab Monotherapy
Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by weekly doses of 2 mg/kg IV beginning on Day 8 and continuing for up to 37 weeks.
干预措施: trastuzumab (Drug)
结局指标
主要结局
Percentage of Participants Progression Free at 12 and 24 Months
时间窗: Months 12 and 24
Progression-Free Survival (PFS) - Percentage of Participants With an Event
时间窗: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.
Progression-Free Survival - Time to Event
时间窗: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
The median time, in months, from the first study drug treatment to a PFS event.
次要结局
- Percentage of Participants by Best Overall Response to Treatment(Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment)
- Overall Survival (OS) - Percentage of Participants With an Event(Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter)
- Percentage of Participants Surviving at 12 and 24 Months(Months 12 and 24)
- Overall Survival - Time to Event(Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter)