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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
  Purpose

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 Intervention
Metastatic Renal Cell Carcinoma
Drug: SUTENT

Study Type: Observational
Study Design: 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®

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 186
Study Start Date: June 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684645

Locations
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, Czech Republic, 100 34
Pfizer Investigational Site
Praha, Czech Republic, 128 08
Pfizer Investigational Site
Praha, Czech Republic, 150 00
Pfizer Investigational Site
Praha, Czech Republic, 140 59
Pfizer Investigational Site
Praha 5, Czech Republic, 150 00
Pfizer Investigational Site
Zlin, Czech Republic, 639 00
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00684645     History of Changes
Other Study ID Numbers: A6181171
Study First Received: May 22, 2008
Results First Received: April 18, 2012
Last Updated: July 17, 2012
Health Authority: Czech Republic: State Institute for Drug Control

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:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014