Carcinoma, HepatocellularNCT01012011
Regulatory Post Marketing Surveillance Study on Nexavar®
An observational study of Carcinoma, Hepatocellular and Carcinoma, Renal Cell, run by Bayer at 1 site in South Korea.
Trial summary
This surveillance are to identify problems/questions regarding adverse events, factors that are considered to affect on safety and efficacy in the clinical practice of using Nexavar Read more about this study
- Who is it for?
- Ages 20 to 91 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Carcinoma, Renal Cell
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- How many people
- 2,845 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Aug 2015
- 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 20 to 91 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of advanced renal cell carcinoma or hepatocellular carcinoma and decision taken by the physician to precribe Nexavar
Who may be able to join
- Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar.
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information but patients who are participating in other interventional studies currently will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This surveillance are to identify problems/questions regarding adverse events, factors that are considered to affect on safety and efficacy in the clinical practice of using Nexavar
Read the detailed description
The objectives of this surveillance are to identify problems/questions regarding the followings in the clinical practice of using Nexavar®.
- Unknown adverse events (in particular, serious adverse events)
- Identification of adverse events occurred in the real practice.
- Factors that are considered to affect on safety.
- Factors that are considered to affect on effectiveness
- Conditions
- Carcinoma, Hepatocellular, Carcinoma, Renal Cell
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- Carcinoma, Hepatocellular, Carcinoma, Renal Cell
- Medical subject headings
- Carcinoma, Hepatocellular, 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
Daily dose, dosage frequency and duration will be decided by physicians.
| 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.
Adverse events collection
Measured: From start of treatment to 4 weeks after discontinuation of treatment
Secondary outcomes (3)
Duration of treatment, dosage and indication
Measured: Whole treatment period
Tumor status
Measured: Whole treatment period
Performance status
Measured: Whole treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- 2,845 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
- NCT01012011
- Sponsor's protocol ID
- 14792
- Other IDs
- NX0910KR
- Status last verified
- Sep 2015
- First submitted
- 10 Nov 2009
- Last updated
- 21 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Post Marketing Surveillance Study on Nexavar®
- ClinicalTrials.gov ID
- NCT01012011
- Acronym / sponsor ID
- 14792
- Conditions
- Carcinoma, Hepatocellular, Carcinoma, Renal Cell
- Keywords
- Carcinoma, Hepatocellular, Carcinoma, Renal Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,845 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Nov 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.
This surveillance are to identify problems/questions regarding adverse events, factors that are considered to affect on safety and efficacy in the clinical practice of using Nexavar
Detailed description
The objectives of this surveillance are to identify problems/questions regarding the followings in the clinical practice of using Nexavar®.
- Unknown adverse events (in particular, serious adverse events)
- Identification of adverse events occurred in the real practice.
- Factors that are considered to affect on safety.
- Factors that are considered to affect on effectiveness
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
- 20 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of advanced renal cell carcinoma or hepatocellular carcinoma and decision taken by the physician to precribe Nexavar
Key inclusion criteria (1 listed)
- Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar.
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the local product information but patients who are participating in other interventional studies currently will be excluded.
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)Daily dose, dosage frequency and duration will be decided by physicians. | Drug | Group 1 |
Primary outcome
Adverse events collection
Time frame: From start of treatment to 4 weeks after discontinuation of treatment
3 secondary outcomes
Duration of treatment, dosage and indication
Time frame: Whole treatment period
Tumor status
Time frame: Whole treatment period
Performance status
Time frame: Whole treatment period
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 21 Sep 2015.
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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, Hepatocellular and Carcinoma, Renal Cell, run by Bayer at 1 site in South Korea.
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 21 Sep 2015. 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 South Korea. 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?
Adverse events collection (time frame: From start of treatment to 4 weeks after discontinuation of treatment). 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 21 Sep 2015.