Gastrointestinal Stromal TumorsNCT01933958
Regorafenib Post-marketing Surveillance in Japan
An observational study of Gastrointestinal Stromal Tumors, run by Bayer at 1 site in Japan.
Trial summary
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
- Gastrointestinal Stromal Tumors
- What is being tested?
- Regorafenib (Stivarga, BAY73-4506)
- Type of treatment
- Pill or oral medicine
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- 4 Sep 2013to 29 Oct 2021
- 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 who are treated with Regorafenib/STIVARGA and meet the product label
Who may be able to join
- Patients who are treated with Regorafenib/ STIVARGA and meet the product label.
Who cannot join
- Patients who are treated with Regorafenib/ STIVARGA and don't meet the product label.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice
Read the detailed description
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 gastrointestinal stromal tumors progressed after cancer chemotherapy.
A total of 135 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months and 24 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Regorafenib (Stivarga, BAY73-4506)
- Keywords
- Regorafenib, Gastrointestinal stromal tumors
- Medical subject headings
- 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
The usual dosage is 160 mg of Regorafenib/ STIVARGA taken orally after meal once daily for 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy. 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
Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib
Measured: up to 6 months
Secondary outcomes (4)
overall survival (OS)
Measured: Up to 3 years
time to treatment failure (TTF)
TTF is defined as the time interval from start of Regorafenib/ STIVARGA therapy to the date of permanent discontinuation for any reason including disease progression, adverse event, patient preference or death.
Measured: Up to 3 years
tumour response
Measured: Up to 3 years
Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor.
Integration analysis including incidence and risk factor of adverse drug reaction (ADR), serious adverse event (SAE) and serious adverse drug reaction (SADR)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study start4 Sep 2013
- Primary completion29 Mar 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal TumorsStudies 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
- 72 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
- NCT01933958
- Sponsor's protocol ID
- 16732
- Other IDs
- STIVARGA-GIST-01
- Status last verified
- Mar 2022
- First submitted
- 29 Aug 2013
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Publications
Komatsu Y, Muro K, Chosa M, Hirano K, Sunaya T, Ayukawa K, Hattori K, Nishida T. Large-scale, prospective observational study of regorafenib in Japanese patients with advanced gastrointestinal stromal tumors in a real-world clinical setting. Front Oncol. 2024 Jun 17;14:1412144. doi: 10.3389/fonc.2024.1412144. eCollection 2024.
PubMed 38952554Komatsu Y, Doi T, Sawaki A, Kanda T, Yamada Y, Kuss I, Demetri GD, Nishida T. Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. Int J Clin Oncol. 2015 Oct;20(5):905-12. doi: 10.1007/s10147-015-0790-y. Epub 2015 Feb 6.
PubMed 25655899
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy
- ClinicalTrials.gov ID
- NCT01933958
- Acronym / sponsor ID
- 16732
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Regorafenib, Gastrointestinal stromal tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2013 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 2 Sep 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.
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice
Detailed description
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 gastrointestinal stromal tumors progressed after cancer chemotherapy.
A total of 135 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months and 24 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)Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are treated with Regorafenib/STIVARGA and meet the product label
Key inclusion criteria (1 listed)
- Patients who are treated with Regorafenib/ STIVARGA and meet the product label.
Key exclusion criteria (1 listed)
- Patients who are treated with Regorafenib/ STIVARGA and don't meet 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 |
|---|---|---|
| Regorafenib (Stivarga, BAY73-4506)The usual dosage is 160 mg of Regorafenib/ STIVARGA taken orally after meal once daily for 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. | 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
Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib
Time frame: up to 6 months
4 secondary outcomes
overall survival (OS)
Time frame: Up to 3 years
time to treatment failure (TTF)
Time frame: Up to 3 years
tumour response
Time frame: Up to 3 years
Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor.
Time frame: Up to 3 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 1 Apr 2022.
- Derived from this study: PubMed 38952554Komatsu Y, Muro K, Chosa M, Hirano K, Sunaya T, Ayukawa K, Hattori K, Nishida T. Large-scale, prospective observational study of regorafenib in Japanese patients with advanced gastrointestinal stromal tumors in a real-world clinical setting. Front Oncol. 2024 Jun 17;14:1412144. doi: 10.3389/fonc.2024.1412144. eCollection 2024.
- Derived from this study: PubMed 25655899Komatsu Y, Doi T, Sawaki A, Kanda T, Yamada Y, Kuss I, Demetri GD, Nishida T. Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. Int J Clin Oncol. 2015 Oct;20(5):905-12. doi: 10.1007/s10147-015-0790-y. Epub 2015 Feb 6.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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 Gastrointestinal Stromal Tumors, 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 1 Apr 2022. 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 3 primary outcomes in all. 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 NCT01933958, which also lists 2 linked publications.
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 1 Apr 2022.