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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment
Metastatic Renal Cell Carcinoma Drug: SUTENT

Detailed Description:
180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.
Study Design
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Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Study Start Date : June 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Overall Survival (OS) [ Time Frame: Baseline to date of death (up to 12 months) ]
    OS is the duration from enrollment to death.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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.

  12. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic and/or advanced renal cell carcinoma after failure of cytokines therapy.
Criteria

Inclusion Criteria:

  • Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria:

  • No previous cytokines therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684645


Locations
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Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 625 00
Pfizer Investigational Site
Brno, Czech Republic, 656 53
Pfizer Investigational Site
Brno, Czech Republic, 656 91
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 5, Czech Republic, 150 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
Zlin, Czech Republic, 639 00
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00684645    
Other Study ID Numbers: A6181171
First Posted: May 26, 2008    Key Record Dates
Results First Posted: August 21, 2012
Last Update Posted: August 21, 2012
Last Verified: July 2012
Keywords provided by Pfizer:
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:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action