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

Completed

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: SUTENT

• Registration Number: NCT00684645
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-26
• Study Start: 2008-06
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-04-18
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-17
• Last Update Submitted: 2012-07-17
• Results First Posted: 2012-08-21
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• Patients with advanced or metastatic renal cell carcinoma.

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Exclusion Criteria

• No previous cytokines therapy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with SUTENT®	SUTENT	Patients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response	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)	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)	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	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	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	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	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	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)	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)	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	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	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇿 Zlin, Czech Republic