Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) Rate
研究概览
简要总结
The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage IIIB, IIIC or IV breast cancer not curable with available therapy.
- •Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.
- •Life expectancy of at least 16 weeks.
- •Ability to swallow whole capsules.
排除标准
- •Use of or requirement for bisphosphonates within 8 weeks prior to screening.
- •Any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ
- •Uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc.
- •Recent or ongoing significant gastrointestinal disorder
研究组 & 干预措施
Advanced breast cancer
干预措施: SKI-606 (Bosutinib) (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) Rate
时间窗: Baseline up to Week 16
PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
时间窗: Baseline up to 30 days after last dose of study treatment
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
次要结局
- Overall Survival (OS)(Baseline up to Year 2)
- Percentage of Participants With Objective Response (OR)(Baseline up to Year 1)
- Percentage of Participants With Clinical Benefit(Baseline up to end of treatment (Week 77))
- Number of Participants With Change From Baseline in Laboratory Test Results(Baseline up to end of treatment (Week 77))
- Number of Participants With Change From Baseline in Electrocardiogram (ECG)(Baseline up to end of treatment (Week 77))
- Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations(Baseline up to end of treatment (Week 77))
- Concomitant Medications Used for Management of Adverse Events (AEs)(Day 1 up to end of treatment (Week 77))
- Change From Baseline in Karnofsky Performance Status (KPS) at Week 1, 4, 8, 12, 16, Every 8 Weeks Thereafter and 14 Days After Last Dose of Study Treatment(Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment)