NCT00662025已完成2 期
A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Number of Participants With Objective Response Based on Data Review Committee's Assessment
研究概览
简要总结
To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent
- •Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
- •Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.
排除标准
- •Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.
- •Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.
- •Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
研究组 & 干预措施
1
Experimental
干预措施: Capecitabine (Drug)
1
Experimental
干预措施: Sunitinib (Drug)
结局指标
主要结局
Number of Participants With Objective Response Based on Data Review Committee's Assessment
时间窗: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
次要结局
- AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)(Day 14 of Cycle 1)
- Number of Participants With Objective Response Based on Investigator's Assessment(Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.)
- Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment(Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.)
- Number of Subjects With CBR Based on Investigator's Assessment(Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.)
- Progression-Free Survival (PFS)(Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.)
- Time to Tumor Progression (TTP)(Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.)
- Duration of Objective Tumor Response (DR)(Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.)
- Time to Objective Tumor Response (TTR)(Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.)
- Overall Survival (OS)(A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study.)
- Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)(Days 14 and 15 of Cycle 1)
- Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)(Days 14 and 15 of Cycle 1)
- Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)(Days 14 and 15 of Cycle 1)
- AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)(Days 14 and 15 of Cycle 1)
- Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)(Day 14 of Cycle 1)
- Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)(Day 14 of Cycle 1)
- t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)(Day 14 of Cycle 1)
研究者
研究点 (1)
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