Carcinoma, Renal CellNCT01728948
Sorafenib in Elderly mRCC
An observational study of Carcinoma, Renal Cell, run by Bayer at 1 site in China.
Trial summary
This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2013to 16 Jan 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: mRCC patients, >= 65 years of age, No prior systemic treatment, need systemic therapy
Who may be able to join
- Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.
- >=65 years of age
- Patients who have signed the informed consent
- Patients with a life expectancy of ≥12 weeks
- No prior systemic treatment
Who cannot join
- The approved local product label must be followed for the exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study of Effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) Treated With Sorafenib
This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- Sorafenib, renal cell carcinoma(RCC), elderly, effectiveness, safety
- 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
treatment (including dose, duration, modification) decided by the investigator
| 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.
Overall survival
Measured: up to 2.5 years
Secondary outcomes (8)
Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
Measured: up to 2.5 years
Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
Measured: up to 2.5 years
Survival rate by one year
Measured: up to 1 year
Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability
Measured: up to 3.5 years
Patient characteristics (birthdate (at least year), sex, weight, height, etc)
Measured: up to 2.5 years
Response rate (RR)
Measured: up to 3.5 years
Time to first relief of clinical symptoms and physical signs
Measured: up to 3.5 years
Treatment pattern
Measured: up to 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study start6 Jan 2013
- Primary completion4 Jan 2016
- Study completion16 Jan 2017
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
- 60 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
- NCT01728948
- Sponsor's protocol ID
- 16399
- Other IDs
- NX1212CN
- Status last verified
- Nov 2017
- First submitted
- 14 Nov 2012
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study of Effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) Treated With Sorafenib
- ClinicalTrials.gov ID
- NCT01728948
- Acronym / sponsor ID
- 16399
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Sorafenib, renal cell carcinoma(RCC), elderly, effectiveness, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2013 (actual)
- Primary completion
- 4 Jan 2016 (actual)
- Study completion
- 16 Jan 2017 (actual)
- First posted
- 20 Nov 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 prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.
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
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- mRCC patients, >= 65 years of age, No prior systemic treatment, need systemic therapy
Key inclusion criteria (5 listed)
- Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.
- >=65 years of age
- Patients who have signed the informed consent
- Patients with a life expectancy of ≥12 weeks
- No prior systemic treatment
Key exclusion criteria (1 listed)
- The approved local product label must be followed for the exclusion criteria
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)treatment (including dose, duration, modification) decided by the investigator | Drug | Group 1 |
Primary outcome
Overall survival
Time frame: up to 2.5 years
8 secondary outcomes
Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
Time frame: up to 2.5 years
Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
Time frame: up to 2.5 years
Survival rate by one year
Time frame: up to 1 year
Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability
Time frame: up to 3.5 years
Patient characteristics (birthdate (at least year), sex, weight, height, etc)
Time frame: up to 2.5 years
Response rate (RR)
Time frame: up to 3.5 years
Time to first relief of clinical symptoms and physical signs
Time frame: up to 3.5 years
Treatment pattern
Time frame: up to 3.5 years
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 2017.
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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 China.
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 5 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 9 Nov 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 China. 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?
Overall survival (time frame: up to 2.5 years). 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 2017.