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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00684645
First received: May 22, 2008
Last updated: July 17, 2012
Last verified: July 2012

May 22, 2008
July 17, 2012
June 2008
April 2011   (final data collection date for primary outcome measure)
  • Percentage of Participants With Objective Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • Correlation between sunitinib-induced hypertension and tumour response to treatment. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Typical profile of patients treated in Czech Republic. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Frequency of sunitinib-induced hypertension, most frequent grade of hypertension. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Observation of dose modifications. Dose modification to be observed mostly and its relevance to adverse effect(s). [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00684645 on ClinicalTrials.gov Archive Site
Not Provided
  • Prevalence of hypothyroidism. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Tumour response to treatment. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Summary of Adverse Events for Participants Who Required Dose Modification [ Time Frame: Baseline up to 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
 
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.

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Metastatic Renal Cell Carcinoma
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.
Patients treated with SUTENT®
Patients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy.
Intervention: Drug: SUTENT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria:

  • No previous cytokines therapy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00684645
A6181171
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP