Advanced or Metastatic Renal Cell CarcinomaNCT00873210
Study In Patients With Kidney Cancer Treated With Sutent
An observational study of Advanced or Metastatic Renal Cell Carcinoma and Renal Cancer, run by Pfizer at 14 sites in Slovakia.
Trial summary
Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Renal Cell Carcinoma, Renal Cancer
- What is being tested?
- Sutent
- How many people
- 121 participants
- Where
- 14 sitesSlovakia
- Study dates
- May 2009to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy.
Who may be able to join
- Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Who cannot join
- Hypersensitivity to sunitinib malate or to any of the excipients
- Any other contraindication to the use of sunitinib malate (based on decision of the treating physician).
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Slovakia14 sites
Pfizer Investigational Site
Banská Bystrica, 975 17
Pfizer Investigational Site
Bojnice, 972 01
Pfizer Investigational Site
Bratislava, 812 50
Pfizer Investigational Site
Bratislava, 833 10
Pfizer Investigational Site
Košice, 043 91
Pfizer Investigational Site
Michalovce, 071 01
Pfizer Investigational Site
Nitra, 949 01
Pfizer Investigational Site
Poprad, 058 01
Pfizer Investigational Site
Prešov, 081 81
Pfizer Investigational Site
Ružomberok, 034 26
Pfizer Investigational Site
Trebišov, 075 01
Pfizer Investigational Site
Trenčín, 911 71
Pfizer Investigational Site
Trnava, 917 75
Pfizer Investigational Site
Žilina, 012 07
About this study
Official title: Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent
Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.
Read the detailed description
Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
- Being tested
- Sutent
- Keywords
- renal cell carcinoma, sunitinib malate
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutentDrug
Also called sunitinib malate
50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Sutent | 125 consecutive patients in outpatient care with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy Receives: Drug: Sutent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib
Measured: 36 months
Secondary outcomes (5)
Dose modifications
Measured: 36 months
Incidence of new diagnosed hypertension
Measured: 36 months
Incidence of new diagnosed hypothyroidism
Measured: 36 months
Safety of sunitinib malate in "real-life" setting
Measured: 36 months
Efficacy of sunitinib malate in "real-life" setting
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 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
- NCT00873210
- Sponsor's protocol ID
- A6181185
- Status last verified
- Nov 2012
- First submitted
- 30 Mar 2009
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 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
- NCT00873210
- Acronym / sponsor ID
- A6181185
- Keywords
- renal cell carcinoma, sunitinib malate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.
Detailed description
Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Sutent | – | Drug: Sutent125 consecutive patients in outpatient care with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy.
Key inclusion criteria (1 listed)
- Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Key exclusion criteria (2 listed)
- Hypersensitivity to sunitinib malate or to any of the excipients
- Any other contraindication to the use of sunitinib malate (based on decision of the treating physician).
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 |
|---|---|---|
| SutentAlso: sunitinib malate50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause | Drug | Patients treated with Sutent |
Primary outcome
Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib
Time frame: 36 months
5 secondary outcomes
Dose modifications
Time frame: 36 months
Incidence of new diagnosed hypertension
Time frame: 36 months
Incidence of new diagnosed hypothyroidism
Time frame: 36 months
Safety of sunitinib malate in "real-life" setting
Time frame: 36 months
Efficacy of sunitinib malate in "real-life" setting
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
- 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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced or Metastatic Renal Cell Carcinoma and Renal Cancer, run by Pfizer at 14 sites in Slovakia.
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 2 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 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Slovakia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib (time frame: 36 months). 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 9 Nov 2012.