PHASE 2 STUDY OF AG-013736 AS SECOND-LINE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CANCER
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 64
- 试验地点
- 18
- 主要终点
- Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment
研究概览
简要总结
To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients histologically diagnosed as metastatic renal cell cancer with a component of clear cell cancer.
- •Patients who are refractory to cytokine therapy as 1st line.
- •Patients who experienced nephrectomy.
- •Patients with at least 1 target lesion, as defined by RECIST.
- •Patients with no uncontrolled hypertension.
排除标准
- •Gastrointestinal abnormalities
- •Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4 inducers.
- •Active seizure disorder or evidence of brain metastases.
- •Patients with hemoptysis.
研究组 & 干预措施
AG-013736
干预措施: AG-013736 (Drug)
结局指标
主要结局
Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment
时间窗: Up to 765 days of treatment at the data cut-off date
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.
Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment
时间窗: Up to 765 days of treatment at the data cut-off date
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.
次要结局
- Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)(Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days))
- Progression-Free Survival (PFS)(Up to 1709 days of treatment)
- Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)(Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days))
- Time to Tumor Progression (TTP)(Up to 1709 days of treatment)
- Overall Survival (OS)(Up to 2002 days (maximum duration of treatment plus follow-up observation))
- Duration of Response(Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment, whichever came first, assessed up to 1709 days.)
- Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)(Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days))
- Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)(Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days))
- Number of Participants With Adverse Events(Up to 1709 days of treatment plus 28-days follow-up)
- Number of Participants Analyzed for Population Pharmacokinetics of AG-013736(Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose)
- Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)(Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days))