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

NCT00684645 | Completed Results

• 1 other identifier: A6181171
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 20

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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Safety and tolerability of SUTENT® in patients with metastatic or advanced renal cell carcinoma after failure of cytokines in real-life setting.

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (3)

• Summary of Adverse Events for Participants Who Required Dose Modification

  Baseline up to 12 months

• Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade

  Baseline up to 12 months

• Percentage of Participants Responding to Treatment

  12 months

Study Arms (1)

Patients treated with SUTENT®

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

Drug: SUTENT

Interventions

SUTENT DRUG

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®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients with advanced or metastatic renal cell carcinoma.

You may not qualify if:

• No previous cytokines therapy.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (20)

Pfizer Investigational Site

Brno, 625 00, Czechia

Location

Pfizer Investigational Site

Brno, 656 53, Czechia

Location

Pfizer Investigational Site

Brno, 656 91, Czechia

Location

Pfizer Investigational Site

Chomutov, 430 12, Czechia

Location

Pfizer Investigational Site

České Budějovice, 370 87, Czechia

Location

Pfizer Investigational Site

Fryštát, 735 06, Czechia

Location

Pfizer Investigational Site

Hradec Králové, 500 05, Czechia

Location

Pfizer Investigational Site

Jihlava, 586 33, Czechia

Location

Pfizer Investigational Site

Liberec, 460 63, Czechia

Location

Pfizer Investigational Site

Nová Ves pod Pleší, 26204, Czechia

Location

Pfizer Investigational Site

Nový Jičín, 741 01, Czechia

Location

Pfizer Investigational Site

Ostrava, 703 84, Czechia

Location

Pfizer Investigational Site

Ostrava, 708 52, Czechia

Location

Pfizer Investigational Site

Pardubice, 532 03, Czechia

Location

Pfizer Investigational Site

Pilsen, 301 00, Czechia

Location

Pfizer Investigational Site

Prague, 100 34, Czechia

Location

Pfizer Investigational Site

Prague, 128 08, Czechia

Location

Pfizer Investigational Site

Prague, 140 59, Czechia

Location

Pfizer Investigational Site

Prague, 150 00, Czechia

Location

Pfizer Investigational Site

Zlín, 639 00, Czechia

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 21, 2012
• Results First Posted: August 21, 2012

Record last verified: 2012-07

Locations

CZ (20)