Carcinoma, Renal CellNEXSTNCT01557127
Nexavar Dosing in Renal Cancer Patients in "Real-life" Setting
An observational study of Carcinoma, Renal Cell, run by Bayer at 1 site in Poland.
Trial summary
This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in "real-life" setting vs. the prescribed dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- How many people
- 205 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2011to 31 Mar 2016
- 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: Adult patients with renal cell carcinoma scheduled to treatment with sorafenib, following therapy failure with IFN/IL-2
Who may be able to join
- Age >/= 18 years
- Diagnosis of renal cell carcinoma
- Failure of prior therapy with interferon-alfa (IFN) or interleukine-2 (IL-2) or disqualified from therapy with IFN/IL-2
- Patients in whom the oncologist has decide to start therapy with sorafenib.
Who cannot join
- Synonymous with contraindications to Nexavar.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma
This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in "real-life" setting vs. the prescribed dose.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- Renal cell carcinoma,, Sorafenib, Dosing
- 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.
Sorafenib (Nexavar, BAY43-9006)Drug
Patients scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)
| 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.
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
Measured: 12 months
Secondary outcomes (1)
Overall tolerability of treatment as measured by rate of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study start1 Nov 2011
- Primary completion16 May 2014
- Study completion31 Mar 2016
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
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557127
- Sponsor's protocol ID
- 16268
- Acronym
- NEXST
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2012
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01557127
- Acronym / sponsor ID
- NEXST / 16268
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Renal cell carcinoma,, Sorafenib, Dosing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 16 May 2014 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 19 Mar 2012 (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.
This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in "real-life" setting vs. the prescribed dose.
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
- Adult patients with renal cell carcinoma scheduled to treatment with sorafenib, following therapy failure with IFN/IL-2
Key inclusion criteria (4 listed)
- Age >/= 18 years
- Diagnosis of renal cell carcinoma
- Failure of prior therapy with interferon-alfa (IFN) or interleukine-2 (IL-2) or disqualified from therapy with IFN/IL-2
- Patients in whom the oncologist has decide to start therapy with sorafenib.
Key exclusion criteria (1 listed)
- Synonymous with contraindications to Nexavar.
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 scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid) | Drug | Group 1 |
Primary outcome
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
Time frame: 12 months
1 secondary outcome
Overall tolerability of treatment as measured by rate of adverse events
Time frame: 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 28 Mar 2017.
- Individual participant dataSharing planned: No
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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, run by Bayer at 1 site in Poland.
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 4 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 28 Mar 2017. 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 Poland. 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?
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose (time frame: 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 28 Mar 2017.