Carcinoma, Renal CellNCT00895674
Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar
An observational study of Carcinoma, Renal Cell and Carcinoma, Renal Cell (Advanced), run by Bayer at 18 sites in 18 countries.
Trial summary
Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Carcinoma, Renal Cell (Advanced)
- What is being tested?
- Nexavar (Sorafenib, BAY43-9006)
- How many people
- 2,840 participants
- Where
- 18 sitesin 18 countries
- Study dates
- Jul 2006to Aug 2010
- 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 a diagnosis of advanced RCC
Who may be able to join
- Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Sorafenib
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
About this study
Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.
- Being tested
- Nexavar (Sorafenib, BAY43-9006)
- Keywords
- Advanced Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexavar (Sorafenib, BAY43-9006)Drug
Patients with a diagnosis of advanced RCC
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Nexavar (Sorafenib, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor status
Measured: After about 3, 6, 9 and 12 months
Secondary outcomes (5)
Treatment duration
Measured: At end of study after about 12 months
Safety of sorafenib treatment
Measured: At every documented visit for about 12 months
Progression-free survival
Measured: Calculation at end of study after about 12 months
Status of Metastases
Measured: After about 3, 6, 9 and 12 months
Performance status (ECOG)
Measured: After about 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startJul 2006
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- 2,840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895674
- Sponsor's protocol ID
- 14686
- Other IDs
- NX0601, PREDICT, 12649, 12650, 12943, 12808, 12807, 12806
- Status last verified
- Sep 2010
- First submitted
- 6 May 2009
- Last updated
- 30 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar
- ClinicalTrials.gov ID
- NCT00895674
- Acronym / sponsor ID
- 14686
- Keywords
- Advanced Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,840 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 8 May 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.
Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Nexavar (Sorafenib, BAY43-9006) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of advanced RCC
Key inclusion criteria (1 listed)
- Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Sorafenib
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the local product information
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 |
|---|---|---|
| Nexavar (Sorafenib, BAY43-9006)Patients with a diagnosis of advanced RCC | Drug | Group 1 |
Primary outcome
Tumor status
Time frame: After about 3, 6, 9 and 12 months
5 secondary outcomes
Treatment duration
Time frame: At end of study after about 12 months
Safety of sorafenib treatment
Time frame: At every documented visit for about 12 months
Progression-free survival
Time frame: Calculation at end of study after about 12 months
Status of Metastases
Time frame: After about 3, 6, 9 and 12 months
Performance status (ECOG)
Time frame: After about 3, 6, 9 and 12 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 30 Sep 2010.
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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.
Bayer Study Director study director
Bayer
18 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Renal Cell and Carcinoma, Renal Cell (Advanced), run by Bayer at 18 sites in 18 countries.
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 30 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Argentina, Austria, China, Colombia, Czechia and 13 more countries. 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?
Tumor status (time frame: After about 3, 6, 9 and 12 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 30 Sep 2010.