AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 723
- 试验地点
- 234
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis
- •Evidence of measurable disease
- •Must have failed one prior systemic first-line regimen for metastatic renal cell cancer
排除标准
- •Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy
- •Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug
研究组 & 干预措施
Axitinib
干预措施: Axitinib (AG-013736) (Drug)
Sorafenib
干预措施: Sorafenib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From initiation of treatment up to follow-up period (up to 3 years)
PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: \>=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.
次要结局
- Overall Survival (OS)(From initiation of treatment up to follow-up period (up to 3 years))
- Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score(Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698))
- Objective Response Rate (ORR)(From initiation of treatment up to follow-up period (up to 3 years))
- Duration of Response (DR)(From initiation of treatment up to follow-up period (up to 3 years))
- Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(From initiation of treatment up to follow-up period (up to 3 years))
- Percentage of Participants With Adverse Events (AEs) by Severity(From initiation of treatment up to follow-up period (up to 3 years))
- Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)(From initiation of treatment up to follow-up period (up to 3 years))
- Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology(From initiation of treatment up to follow-up period (up to 3 years))
- Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry(From initiation of treatment up to follow-up period (up to 3 years))
- Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis(From initiation of treatment up to follow-up period (up to 3 years))
- Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score(Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698))
- Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score(Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698))
- Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)(Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698))