Carcinoma, Renal CellNCT01411423
Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan
An observational study of Carcinoma, Renal Cell, run by Bayer at 1 site in Japan.
Trial summary
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- How many people
- 3,305 participants
- Where
- 1 siteJapan
- Study dates
- 18 Apr 2008to 28 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study is all cases investigation of which the enrollment period is 15 months, and all patients who received Nexavar for unresectable or advanced RCC will be recruited.
Who may be able to join
- Patients who received Nexavar for unresectable or advanced renal cell carcinoma
Who cannot join
- Patients who are contraindicated based on the product label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma)
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- Nexavar, Unresectable or advanced renal cell carcinoma
- 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 who have received Nexavar for unresectable or advanced RCC.
| 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.
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
Measured: After Nexavar administration, up to 1 year
Secondary outcomes (3)
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, medical history data, clinical staging, etiology of HCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]
Measured: After Nexavar administration, up to 1 year
Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC]
Measured: After Nexavar administration, up to 1 year
The status of therapy with Nexavar [duration of treatment, daily dose]
Measured: After Nexavar administration, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study start18 Apr 2008
- Primary completion16 Mar 2012
- Study completion28 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,305 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
- NCT01411423
- Sponsor's protocol ID
- 15038
- Other IDs
- NEXAVAR-RCC-02
- Status last verified
- Jun 2018
- First submitted
- 5 Aug 2011
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Inamoto T, Azuma H, Tatsugami K, Oya M, Adachi M, Okayama Y, Sunaya T, Akaza H. Real-world use of sorafenib for advanced renal cell carcinoma patients with cardiovascular disease: nationwide survey in Japan. Expert Rev Anticancer Ther. 2020 Jul;20(7):615-623. doi: 10.1080/14737140.2020.1773805. Epub 2020 Jun 16.
PubMed 32441582
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma)
- ClinicalTrials.gov ID
- NCT01411423
- Acronym / sponsor ID
- 15038
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Nexavar, Unresectable or advanced renal cell carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,305 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2008 (actual)
- Primary completion
- 16 Mar 2012 (actual)
- Study completion
- 28 Feb 2016 (actual)
- First posted
- 8 Aug 2011 (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 regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Sorafenib (Nexavar, BAY43-9006) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is all cases investigation of which the enrollment period is 15 months, and all patients who received Nexavar for unresectable or advanced RCC will be recruited.
Key inclusion criteria (1 listed)
- Patients who received Nexavar for unresectable or advanced renal cell carcinoma
Key exclusion criteria (1 listed)
- Patients who are contraindicated based on the product label
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 who have received Nexavar for unresectable or advanced RCC. | Drug | Group 1 |
Primary outcome
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
Time frame: After Nexavar administration, up to 1 year
3 secondary outcomes
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, medical history data, clinical staging, etiology of HCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]
Time frame: After Nexavar administration, up to 1 year
Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC]
Time frame: After Nexavar administration, up to 1 year
The status of therapy with Nexavar [duration of treatment, daily dose]
Time frame: After Nexavar administration, up to 1 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 6 Jun 2018.
- Derived from this study: PubMed 32441582Inamoto T, Azuma H, Tatsugami K, Oya M, Adachi M, Okayama Y, Sunaya T, Akaza H. Real-world use of sorafenib for advanced renal cell carcinoma patients with cardiovascular disease: nationwide survey in Japan. Expert Rev Anticancer Ther. 2020 Jul;20(7):615-623. doi: 10.1080/14737140.2020.1773805. Epub 2020 Jun 16.
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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 Japan.
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 6 Jun 2018. 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 Japan. 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?
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar (time frame: After Nexavar administration, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01411423, which also lists 1 linked publication.
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 6 Jun 2018.