Metastatic Renal Cell CarcinomaNCT00684645
Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
An observational study of Metastatic Renal Cell Carcinoma, run by Pfizer at 20 sites in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- SUTENT
- Type of treatment
- Pill or oral medicine
- How many people
- 186 participants
- Where
- 20 sitesCzechia
- Study dates
- Jun 2008to Apr 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic and/or advanced renal cell carcinoma after failure of cytokines therapy.
Who may be able to join
- Patients with advanced or metastatic renal cell carcinoma.
Who cannot join
- No previous cytokines therapy.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Czechia20 sites
Pfizer Investigational Site
Brno, 625 00
Pfizer Investigational Site
Brno, 656 53
Pfizer Investigational Site
Brno, 656 91
Pfizer Investigational Site
České Budějovice, 370 87
Pfizer Investigational Site
Chomutov, 430 12
Pfizer Investigational Site
Fryštát, 735 06
Pfizer Investigational Site
Hradec Králové, 500 05
Pfizer Investigational Site
Jihlava, 586 33
Pfizer Investigational Site
Liberec, 460 63
Pfizer Investigational Site
Nová Ves pod Pleší, 26204
Pfizer Investigational Site
Nový Jičín, 741 01
Pfizer Investigational Site
Ostrava, 703 84
Pfizer Investigational Site
Ostrava, 708 52
Pfizer Investigational Site
Pardubice, 532 03
Pfizer Investigational Site
Pilsen, 301 00
Pfizer Investigational Site
Prague, 100 34
Pfizer Investigational Site
Prague, 128 08
Pfizer Investigational Site
Prague, 140 59
Pfizer Investigational Site
Prague, 150 00
Pfizer Investigational Site
Zlín, 639 00
About this study
Official title: 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.
Read the detailed description
180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- SUTENT
- Keywords
- Safety and tolerability of SUTENT® in patients with metastatic or advanced renal cell carcinoma after failure of cytokines in real-life setting.
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUTENTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with SUTENT® | Patients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy. Receives: Drug: SUTENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Progression-free Survival (PFS)
The period from study entry until disease progression, death, or date of last contact.
Measured: Baseline to measured progressive disease (up to 12 months)
Overall Survival (OS)
OS is the duration from enrollment to death.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6, Months 3, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684645
- Sponsor's protocol ID
- A6181171
- Status last verified
- Jul 2012
- First submitted
- 22 May 2008
- Last updated
- 21 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
- ClinicalTrials.gov ID
- NCT00684645
- Acronym / sponsor ID
- A6181171
- 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.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 21 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with SUTENT® | – | Drug: SUTENTPatients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic and/or advanced renal cell carcinoma after failure of cytokines therapy.
Key inclusion criteria (1 listed)
- Patients with advanced or metastatic renal cell carcinoma.
Key exclusion criteria (1 listed)
- No previous cytokines therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUTENTSUTENT® 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. | Drug | Patients treated with SUTENT® |
Primary outcome
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.
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.
Overall Survival (OS)
Time frame: Baseline to date of death (up to 12 months)
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
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
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
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
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
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)
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)
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma, run by Pfizer at 20 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Objective Response (time frame: 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.