Exploratory Evaluation Of A Sequential Administration Of Docetaxel And SU011248 In Women With Advanced Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
研究概览
简要总结
This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer 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
- •Candidate for treatment with docetaxel
排除标准
- •Prior chemotherapy in the advanced disease setting
- •Inflammatory breast cancer
- •HER2 positive disease
研究组 & 干预措施
1
干预措施: Sunitinib (Sutent) (Drug)
1
干预措施: Taxotere (Drug)
结局指标
主要结局
Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
时间窗: 1, 2, 4, 6, 8, 12, 24 hours postdose
Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.
Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
时间窗: 1, 2, 4, 6, 8, 12, 24 hours postdose
Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
时间窗: 1, 2, 4, 6, 8, 12, 24 hours postdose
Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng\*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
时间窗: 1, 2, 4, 6, 8, 12, 24 hours postdose
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.
Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
时间窗: 0 hour postdose
Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.
Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters
时间窗: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.
Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters
时间窗: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters
时间窗: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.
Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters
时间窗: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.
Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters
时间窗: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean AUC24_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters
时间窗: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.
Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters
时间窗: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.
次要结局
- Progression-Free Survival (PFS) Based on Investigator Assessment(First dose of study treatment until progressive disease)
- Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment(First dose of study treatment until at least 4 weeks after confirmed response or partial response)
- Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment(First dose of study treatment until at least 24 weeks on study)
- Duration of Tumor Response Based on Investigator Assessment(Start of first confirmed CR or PR to first confirmed progression or death)