Colorectal NeoplasmsStivargaPMSNCT02106858
Stivarga Regulatory Post-Marketing Surveillance Study in Korea
An observational study of Colorectal Neoplasms, run by Bayer at 1 site in South Korea.
Trial summary
To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Regorafenib (Stivarga,BAY73-4506)
- How many people
- 316 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2014to 7 May 2019
- 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: Patients diagnosed with metastatic colorectal cancer or metastatic or unresectable locally advanced GIST(Gastrointestinal stromal tumors) by physician.
Who may be able to join
- Signed and dated informed consent
- Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician
- Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice
- All contra-indications according to the local marketing authorization have to be considered.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stivarga® Regulatory Post-Marketing Surveillance Study in Korea
To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.
- Conditions
- Colorectal Neoplasms
- Being tested
- Regorafenib (Stivarga,BAY73-4506)
- Keywords
- Stivarga / Regorafenib / Metastatic Colorectal Cancer / Metastatic or unresectable locally advanced GIST (Gastrointestinal stromal tumors)
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib (Stivarga,BAY73-4506)Drug
Patients treated by Physician with Stivarga under approved local prescriptions
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients treated by Physician with Stivarga under approved local prescriptions Receives: Drug: Regorafenib (Stivarga,BAY73-4506) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with serious adverse events
Every 2 months (monthly safety assessment within first two cycles)
Measured: Up to 30 days after terminating treatment
Percentage of patients with adverse drug reactions (ADRs)
Every 2 months (monthly safety assessment within first two cycles)
Measured: Up to 30 days after terminating treatment
Secondary outcomes (3)
Overall response
Measured: Up to 6 years
Progression free survival (PFS)
Measured: Up to 6 years
Overall survival (OS)
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start25 Jun 2014
- Primary completion7 May 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- 316 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
- NCT02106858
- Sponsor's protocol ID
- 16778
- Other IDs
- SV1314KR
- Acronym
- StivargaPMS
- Status last verified
- Jul 2023
- First submitted
- 4 Apr 2014
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stivarga® Regulatory Post-Marketing Surveillance Study in Korea
- ClinicalTrials.gov ID
- NCT02106858
- Acronym / sponsor ID
- StivargaPMS / 16778
- Conditions
- Colorectal Neoplasms
- Keywords
- Stivarga / Regorafenib / Metastatic Colorectal Cancer / Metastatic or unresectable locally advanced GIST (Gastrointestinal stromal tumors)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2014 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 8 Apr 2014 (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.
To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Regorafenib (Stivarga,BAY73-4506)Patients treated by Physician with Stivarga under approved local prescriptions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with metastatic colorectal cancer or metastatic or unresectable locally advanced GIST(Gastrointestinal stromal tumors) by physician.
Key inclusion criteria (3 listed)
- Signed and dated informed consent
- Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician
- Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time
Key exclusion criteria (2 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice
- All contra-indications according to the local marketing authorization have to be considered.
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 |
|---|---|---|
| Regorafenib (Stivarga,BAY73-4506)Patients treated by Physician with Stivarga under approved local prescriptions | Drug | Group 1 |
Primary outcome
Percentage of patients with serious adverse events
Time frame: Up to 30 days after terminating treatment
Every 2 months (monthly safety assessment within first two cycles)
Percentage of patients with adverse drug reactions (ADRs)
Time frame: Up to 30 days after terminating treatment
Every 2 months (monthly safety assessment within first two cycles)
3 secondary outcomes
Overall response
Time frame: Up to 6 years
Progression free survival (PFS)
Time frame: Up to 6 years
Overall survival (OS)
Time frame: Up to 6 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 24 Jul 2023.
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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 Colorectal Neoplasms, 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 3 inclusion and 2 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 24 Jul 2023. 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?
Percentage of patients with serious adverse events (time frame: Up to 30 days after terminating treatment). The study lists 2 primary outcomes in all. 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 24 Jul 2023.