Colorectal NeoplasmsNCT01843400
Regorafenib Post-marketing Surveillance
An observational study of Colorectal Neoplasms, 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 received Regorafenib for colorectal cancer. The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice. 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
- 1,301 participants
- Where
- 1 siteJapan
- Study dates
- 22 Apr 2013to 14 Nov 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: Patients with unresectable, metastatic or recurrent colorectal cancer
Who may be able to join
- who are determined to start Regorafenib/ STIVARGA treatment
Who cannot join
- Patients who have previously received Regorafenib/ STIVARGA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer.
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.
A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.
- Conditions
- Colorectal Neoplasms
- Being tested
- Regorafenib (Stivarga, BAY73-4506)
- Keywords
- Regorafenib, Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms
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 with Regorafenib under practical manner for colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Regorafenib (Stivarga, BAY73-4506) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib
Measured: Up to 6 months
Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
Measured: up to 6 months
Secondary outcomes (7)
Number of pateints with ADRs in subpopulations
Measured: Up to 6 months
Number of patients with SAEs in supopulations
Measured: Up to 6 months
Overall survival (OS)
Measured: Up to 12 months
Overall survival in subpopulations
Measured: Up to 12 months
Time to treatment failure (TTF)
Measured: Up to 12 months
Time to Treatment failure in subpopulations
Measured: Up to 12 months
Tumor response assessed by RECIST or physicians own evaluation
RECIST: Response Evaluation Criteria In Solid Tumors
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study start22 Apr 2013
- Primary completion12 Sep 2016
- Study completion14 Nov 2016
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
- 1,301 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
- NCT01843400
- Sponsor's protocol ID
- 16472
- Other IDs
- STIVARGA-CRC-01
- Status last verified
- Jul 2018
- First submitted
- 26 Apr 2013
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01843400
- Acronym / sponsor ID
- 16472
- Conditions
- Colorectal Neoplasms
- Keywords
- Regorafenib, Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,301 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2013 (actual)
- Primary completion
- 12 Sep 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 30 Apr 2013 (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 received Regorafenib for colorectal cancer.
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.
A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Regorafenib (Stivarga, BAY73-4506) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with unresectable, metastatic or recurrent colorectal cancer
Key inclusion criteria (1 listed)
- who are determined to start Regorafenib/ STIVARGA treatment
Key exclusion criteria (1 listed)
- Patients who have previously received Regorafenib/ STIVARGA
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 with Regorafenib under practical manner for colorectal cancer. | Drug | Group 1 |
Primary outcome
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib
Time frame: Up to 6 months
Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
Time frame: up to 6 months
7 secondary outcomes
Number of pateints with ADRs in subpopulations
Time frame: Up to 6 months
Number of patients with SAEs in supopulations
Time frame: Up to 6 months
Overall survival (OS)
Time frame: Up to 12 months
Overall survival in subpopulations
Time frame: Up to 12 months
Time to treatment failure (TTF)
Time frame: Up to 12 months
Time to Treatment failure in subpopulations
Time frame: Up to 12 months
Tumor response assessed by RECIST or physicians own evaluation
Time frame: Up to 6 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 2 Aug 2018.
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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 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 2 Aug 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?
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib (time frame: Up to 6 months). 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 2 Aug 2018.