Carcinoma, Renal CellPONDIACNCT00771147
A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ®
An observational study of Carcinoma, Renal Cell and Carcinoma, Renal Cell (Advanced), run by Bayer at 1 site in Belgium.
Trial summary
Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs. 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?
- Sorafenib (Nexavar, BAY43-9006)
- How many people
- 71 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2008to Nov 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 diagnosis of advanced Renal Cell Carcimona
Who may be able to join
- Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Nexavar®. The patients should have sufficient knowledge of French or Dutch to be able to participate in the Study
Who cannot join
- Exclusion criteria must be read in conjunction with the Belgian product information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Open-label Non-interventional, Non-controlled Multi Observational and Pharmaco-economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-life Treatment Conditions
Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- Advanced Renal Cell Carcinoma ( RCC)
- 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.
Sorafenib (Nexavar, BAY43-9006)Drug
Patients with diagnosis of advanced renal cell cancer and decision taken by the investigator to prescribe Nexavar®.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated
Measured: At 1, 3, 6 and 9 months and after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startJun 2008
- Study completionNov 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
- 71 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
- NCT00771147
- Sponsor's protocol ID
- 13102
- Other IDs
- NX0710BE
- Acronym
- PONDIAC
- Status last verified
- Jun 2012
- First submitted
- 9 Oct 2008
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open-label Non-interventional, Non-controlled Multi Observational and Pharmaco-economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-life Treatment Conditions
- ClinicalTrials.gov ID
- NCT00771147
- Acronym / sponsor ID
- PONDIAC / 13102
- Keywords
- Advanced Renal Cell Carcinoma ( RCC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Oct 2008 (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.
Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Sorafenib (Nexavar, 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 diagnosis of advanced Renal Cell Carcimona
Key inclusion criteria (1 listed)
- Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Nexavar®. The patients should have sufficient knowledge of French or Dutch to be able to participate in the Study
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the Belgian 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 |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006)Patients with diagnosis of advanced renal cell cancer and decision taken by the investigator to prescribe Nexavar®. | Drug | Group 1 |
Primary outcome
Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated
Time frame: At 1, 3, 6 and 9 months and after one year
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 15 Jun 2012.
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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
1 site in 1 country: 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 1 site in Belgium.
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 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated (time frame: At 1, 3, 6 and 9 months and after one year). 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 15 Jun 2012.