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

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684645
• Other study ID #: A6181171
• Status: Completed
• Phase: N/A
• First received: May 22, 2008
• Last updated: July 17, 2012
• Start date: June 2008
• Est. completion date: April 2011

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria:

• No previous cytokines therapy.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• 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.

Locations

Country	Name	City	State
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Ceske Budejovice
Czech Republic	Pfizer Investigational Site	Chomutov
Czech Republic	Pfizer Investigational Site	Hradec kralove
Czech Republic	Pfizer Investigational Site	Jihlava
Czech Republic	Pfizer Investigational Site	Karvina
Czech Republic	Pfizer Investigational Site	Liberec
Czech Republic	Pfizer Investigational Site	Nova Ves pod Plesi
Czech Republic	Pfizer Investigational Site	Novy Jicin
Czech Republic	Pfizer Investigational Site	Ostrava
Czech Republic	Pfizer Investigational Site	Ostrava
Czech Republic	Pfizer Investigational Site	Pardubice
Czech Republic	Pfizer Investigational Site	Plzen
Czech Republic	Pfizer Investigational Site	Praha
Czech Republic	Pfizer Investigational Site	Praha
Czech Republic	Pfizer Investigational Site	Praha
Czech Republic	Pfizer Investigational Site	Praha
Czech Republic	Pfizer Investigational Site	Praha 5
Czech Republic	Pfizer Investigational Site	Zlin

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Summary of Adverse Events for Participants Who Required Dose Modification	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.	Baseline up to 12 months	Yes
Other	Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade	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.	Baseline up to 12 months	Yes
Other	Percentage of Participants Responding to Treatment	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.	12 months	No
Primary	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	No
Primary	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)	No
Primary	Overall Survival (OS)	OS is the duration from enrollment to death.	Baseline to date of death (up to 12 months)	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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)	No
Primary	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)	No
Primary	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	Yes
Primary	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	Yes

External Links

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