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临床试验/NCT00684645
NCT00684645已完成不适用

Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

Pfizer1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
186
试验地点
1
主要终点
Percentage of Participants With Objective Response

研究概览

简要总结

Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.

详细描述

180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with advanced or metastatic renal cell carcinoma.

排除标准

  • No previous cytokines therapy.

研究组 & 干预措施

Patients treated with SUTENT®

Patients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy.

干预措施: SUTENT (Drug)

结局指标

主要结局

Percentage of Participants With Objective Response

时间窗: 12 months

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Progression-free Survival (PFS)

时间窗: Baseline to measured progressive disease (up to 12 months)

The period from study entry until disease progression, death, or date of last contact.

Overall Survival (OS)

时间窗: Baseline to date of death (up to 12 months)

OS is the duration from enrollment to death.

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6

时间窗: Week 6

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3

时间窗: Month 3

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6

时间窗: Month 6

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9

时间窗: Month 9

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12

时间窗: Month 12

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.

Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)

时间窗: Baseline to date of first documentation of response to treatment (up to 12 months)

Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension).

Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)

时间窗: Baseline to date of death (up to 12 months)

Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS.

Percentage of Participants With Hypothyroidism

时间窗: Baseline, Months 3, 6, 9, 12

TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level \>5.0 mIU/L at that time point.

Percentage of Participants With Hypertension

时间窗: Baseline, Week 6, Months 3, 6, 9, 12

Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than \[\<\]24 hours) increase by \>20mm Hg (diastolic) or to \>150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by \>20 mm Hg (diastolic) or to \>150/100 mm Hg if previously WNL. Grade 3: Requiring \>1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death.

次要结局

未报告次要终点

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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