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Clinical Trials/NCT00684645
NCT00684645
Completed
Not Applicable

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

Pfizer1 site in 1 country186 target enrollmentJune 2008

Overview

Phase
Not Applicable
Intervention
SUTENT
Conditions
Metastatic Renal Cell Carcinoma
Sponsor
Pfizer
Enrollment
186
Locations
1
Primary Endpoint
Percentage of Participants With Objective Response
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
April 2011
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria

  • No previous cytokines therapy.

Arms & Interventions

Patients treated with SUTENT®

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

Intervention: SUTENT

Outcomes

Primary Outcomes

Percentage of Participants With Objective Response

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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