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

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ClinicalTrials.gov Identifier: NCT00684645
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 22, 2008
First Posted Date May 26, 2008
Results First Submitted Date April 18, 2012
Results First Posted Date August 21, 2012
Last Update Posted Date August 21, 2012
Study Start Date June 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2012)
  • 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.
Original Primary Outcome Measures
 (submitted: May 22, 2008)
  • Typical profile of patients treated in Czech Republic. [ Time Frame: 18 months ]
  • Observation of dose modifications. Dose modification to be observed mostly and its relevance to adverse effect(s). [ Time Frame: 18 months ]
  • Frequency of sunitinib-induced hypertension, most frequent grade of hypertension. [ Time Frame: 18 months ]
  • Correlation between sunitinib-induced hypertension and tumour response to treatment. [ Time Frame: 18 months ]
  • Increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. [ Time Frame: 18 months ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 22, 2008)
  • Prevalence of hypothyroidism. [ Time Frame: 18 months ]
  • Tumour response to treatment. [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures
 (submitted: July 17, 2012)
  • Summary of Adverse Events for Participants Who Required Dose Modification [ Time Frame: Baseline up to 12 months ]
    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.
  • Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade [ Time Frame: Baseline up to 12 months ]
    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.
  • Percentage of Participants Responding to Treatment [ Time Frame: 12 months ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Official Title Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with metastatic and/or advanced renal cell carcinoma after failure of cytokines therapy.
Condition Metastatic Renal Cell Carcinoma
Intervention 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.
Study Groups/Cohorts Patients treated with SUTENT®
Patients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy.
Intervention: Drug: SUTENT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 9, 2011)
186
Original Estimated Enrollment
 (submitted: May 22, 2008)
180
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria:

  • No previous cytokines therapy.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number NCT00684645
Other Study ID Numbers A6181171
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2012