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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Renal Cell Carcinoma
• Intervention / Treatment: Drug: SUTENT

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

Study Locations

• Czech Republic
  • Brno, Czech Republic, 656 91
    • Pfizer Investigational Site
  • Brno, Czech Republic, 656 53
    • Pfizer Investigational Site
  • Brno, Czech Republic, 625 00
    • Pfizer Investigational Site
  • Ceske Budejovice, Czech Republic, 370 87
    • Pfizer Investigational Site
  • Chomutov, Czech Republic, 430 12
    • Pfizer Investigational Site
  • Hradec kralove, Czech Republic, 500 05
    • Pfizer Investigational Site
  • Jihlava, Czech Republic, 586 33
    • Pfizer Investigational Site
  • Karvina, Czech Republic, 735 06
    • Pfizer Investigational Site
  • Liberec, Czech Republic, 460 63
    • Pfizer Investigational Site
  • Nova Ves pod Plesi, Czech Republic, 26204
    • Pfizer Investigational Site
  • Novy Jicin, Czech Republic, 741 01
    • Pfizer Investigational Site
  • Ostrava, Czech Republic, 703 84
    • Pfizer Investigational Site
  • Ostrava, Czech Republic, 708 52
    • Pfizer Investigational Site
  • Pardubice, Czech Republic, 532 03
    • Pfizer Investigational Site
  • Plzen, Czech Republic, 301 00
    • Pfizer Investigational Site
  • Praha, Czech Republic, 100 34
    • Pfizer Investigational Site
  • Praha, Czech Republic, 128 08
    • Pfizer Investigational Site
  • Praha, Czech Republic, 140 59
    • Pfizer Investigational Site
  • Praha, Czech Republic, 150 00
    • Pfizer Investigational Site
  • Praha 5, Czech Republic, 150 00
    • Pfizer Investigational Site
  • Zlin, Czech Republic, 639 00
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria:

• No previous cytokines therapy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with SUTENT®; Patients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy.	Drug: SUTENT; SUTENT® hard gelatin capsules containing 12.5 mg, 25 mg or 50 mg equivalent of sunitinib malate; daily dosage of 50 mg for 4 consecutive weeks followed by a 2-week rest period. Sutent is administered until disease progression or occurrence of unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Objective Response	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.	12 months
Progression-free Survival (PFS)	The period from study entry until disease progression, death, or date of last contact.	Baseline to measured progressive disease (up to 12 months)
Overall Survival (OS)	OS is the duration from enrollment to death.	Baseline to date of death (up to 12 months)
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at 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.	Week 6
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at 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.	Month 3
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at 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.	Month 6
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at 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.	Month 9
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at 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.	Month 12
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)	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).	Baseline to date of first documentation of response to treatment (up to 12 months)
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)	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.	Baseline to date of death (up to 12 months)
Percentage of Participants With Hypothyroidism	TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level >5.0 mIU/L at that time point.	Baseline, Months 3, 6, 9, 12
Percentage of Participants With Hypertension	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.	Baseline, Week 6, Months 3, 6, 9, 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Adverse Events for Participants Who Required Dose Modification	Adverse events (AEs) or treatment-emergent adverse events (TEAEs) were defined as newly occurring or worsening after first dose. Study drug modifications included reduced dose or temporary discontinuation of treatment.	Baseline up to 12 months
Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Sunitinib-induced hypertension: not present at baseline but developed through the study, or if present at baseline increased by more than (>) 20% during the study. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20 millimeters of Mercury (mm Hg) (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL); Grade 2: Recurrent or persistent (>=24 hours) 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.	Baseline up to 12 months
Percentage of Participants Responding to Treatment	Response categories for target lesions: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest dimensions, reference=baseline sum of longest dimensions; Progressive disease (PD): At least a 20% increase in the sum of the longest dimensions, or the appearance of 1 or more new lesions; Stable disease (SD): Not sufficient shrinkage to qualify for PR, not sufficient increase to qualify for PD; Reference for PD and SD: smallest sum of longest dimensions since treatment started.	12 months

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: May 22, 2008
• First Submitted That Met QC Criteria: May 22, 2008
• First Posted (Estimate): May 26, 2008

Study Record Updates

• Last Update Posted (Estimate): August 21, 2012
• Last Update Submitted That Met QC Criteria: July 17, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Safety and tolerability of SUTENT® in patients with metastatic or advanced renal cell carcinoma after failure of cytokines in real-life setting.
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: A6181171