An Explorative Study Of The Tolerability Of SU011248 In Combination With Docetaxel And Trastuzumab As First-Line Treatment In Patients With Breast Cancer Over-Expressing HER-2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
研究概览
简要总结
This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
- •Tumors over-expressing Her-2
- •Candidate for treatment with docetaxel/trastuzumab
排除标准
- •Histology of inflammatory carcinoma
- •AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN
研究组 & 干预措施
1
Combination of SU011248 (37.5 mg once daily [Schedule 2/1]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)
干预措施: Herceptin (Drug)
1
Combination of SU011248 (37.5 mg once daily [Schedule 2/1]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)
干预措施: Sunitinib (Drug)
1
Combination of SU011248 (37.5 mg once daily [Schedule 2/1]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)
干预措施: Taxotere (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: From screening until 28 days post last dose of study drug
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of 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 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
次要结局
- Percentage of Participants With Objective Response (OR)(Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344))
- Progression-free Survival (PFS)(Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344))
- Duration of Response (DR)(Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344))
- Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662)(Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1)
- Maximum Observed Plasma Concentration (Cmax) of Docetaxel(End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6)
- Plasma Trough Concentrations (Ctrough) of Trastuzumab(Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6)