Metastatic Colorectal CancerCOLONGERNCT06029010
An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metastatic Colorectal Cancer in the United States
An observational study of Metastatic Colorectal Cancer, run by Bayer at 1 site in United States.
Trial summary
This is an observational study in which data already collected from patients with metastatic colorectal cancer will be studied. Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus) that has spread to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Regorafenib (Stivarga, BAY73-4506)
- How many people
- 2,326 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 27 Jan 2025
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Data for the study will be obtained from the Flatiron Health Data Repository; an electronic health record (EHR)-derived longitudinal demographically and geographically diverse database of oncology patients in routine clinical practice in the US. Patients with mCRC who initiated regorafenib treatment between 1 JUL 2013 and 31 DEC 2022 will be followed through the electronic data from the start of regorafenib treatment until the date of death for patients who died, and the date of last visit on or up to 31 MAY 2023 for patients with no record of death.
Who may be able to join
- Patients with a diagnosis of mCRC between 1 JAN 2013 and 31 DEC 2022 who initiated regorafenib monotherapy up to 14 days prior or after mCRC diagnosis and during the patient selection period (1 JUL 2013 to 31 DEC 2022).
- Adult patients (≥18 years old) at index date (date of first regorafenib treatment).
- Patients with at least one recorded visit, laboratory test, or other recorded electronic medical record (EMR) entry (e.g., treatment) in the Flatiron network at least 3 months prior to the index date, unless the patient was diagnosed with mCRC within the last 3 months.
Who cannot join
- Patients who had a diagnosis or recorded history of gastrointestinal stromal tumor (GISC), hepatocellular cancer (HCC), or other primary cancers (except non-melanoma skin cancers) during the 6-month period on or prior to the index date.
- For analyses of long-term responders, patients will be excluded if treatment duration <5 and <4 months for treatment completers, or treatment duration <5 and <4 months at last visit date for non-completers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Many Locations
Multiple Locations, New Jersey, 07981
About this study
Official title: Real-world Study in Metastatic Colorectal Cancer Patients With Long-term Responses to Regorafenib in the US
This is an observational study in which data already collected from patients with metastatic colorectal cancer will be studied.
Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus) that has spread to other parts of the body.
Read more
The study drug, regorafenib, is already approved for cancer doctors to prescribe to patients with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer.
The participants in this study were treated with regorafenib as part of their regular care from their doctors.
Some studies have shown that patients with mCRC who took regorafenib had improved survival outcomes, and some of them did well on the treatment for a long time. Cancer doctors have also reported from their routine practice that some patients with mCRC are able to respond to regorafenib for a longer period than others. However, there is limited knowledge about which people this is likely to happen for.
To better understand the long-term response of regorafenib treatment, there is a need for a large-scale study in the real world.
The main purpose of this study is to learn more about patients who showed a long-term response to regorafenib as a mono treatment for mCRC. To do this, researchers will collect the following information from the participants' health records:
Duration of treatment with regorafenib
Percentage of participants who received treatment with regorafenib for at least 5 months and 4 months.
Characteristics, including age, sex, race, health condition, and signs and symptoms of mCRC, of participants who received treatment with regorafenib for at least 5 months and 4 months.
The data will come from an electronic health records database called the Flatiron Health Data Repository for patients in the United States. The data will be from patients with mCRC who started treatment with regorafenib between July 2013 and December 2022.
Researchers will consider the data of the participants collected until May 2023.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Regorafenib (Stivarga, BAY73-4506)
- Keywords
- mCRC
- 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
Follow clinical administration.
| Study group | Role | What they receive |
|---|---|---|
| Long-term responders of regorafenib ≥5 months | Defined as treatment duration ≥5 months after treatment initiation. Receives: Drug: Regorafenib (Stivarga, BAY73-4506) | |
| Long-term responders of regorafenib ≥4 months | Defined as treatment duration ≥4 months after treatment initiation. Receives: Drug: Regorafenib (Stivarga, BAY73-4506) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
Measured: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Demographic characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
Measured: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Descriptive analysis of clinical characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
Measured: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Descriptive analysis of biomarkers of patients with mCRC who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
Measured: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Secondary outcomes (4)
Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
Measured: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Demographic characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
Measured: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Descriptive analysis of clinical characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
Measured: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Descriptive analysis of biomarkers of patients with mCRC who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
Measured: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start31 Aug 2023
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- Retrospective
- Enrolment
- 2,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029010
- Sponsor's protocol ID
- 22624
- Acronym
- COLONGER
- Status last verified
- Feb 2025
- First submitted
- 1 Sep 2023
- Last updated
- 26 Feb 2025
- 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, timepoint 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.vivli.org 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 member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study in Metastatic Colorectal Cancer Patients With Long-term Responses to Regorafenib in the US
- ClinicalTrials.gov ID
- NCT06029010
- Acronym / sponsor ID
- COLONGER / 22624
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- mCRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,326 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 8 Sep 2023 (actual)
- 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 is an observational study in which data already collected from patients with metastatic colorectal cancer will be studied.
Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus) that has spread to other parts of the body.
The study drug, regorafenib, is already approved for cancer doctors to prescribe to patients with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer.
The participants in this study were treated with regorafenib as part of their regular care from their doctors.
Some studies have shown that patients with mCRC who took regorafenib had improved survival outcomes, and some of them did well on the treatment for a long time. Cancer doctors have also reported from their routine practice that some patients with mCRC are able to respond to regorafenib for a longer period than others. However, there is limited knowledge about which people this is likely to happen for.
To better understand the long-term response of regorafenib treatment, there is a need for a large-scale study in the real world.
The main purpose of this study is to learn more about patients who showed a long-term response to regorafenib as a mono treatment for mCRC. To do this, researchers will collect the following information from the participants' health records:
Duration of treatment with regorafenib
Percentage of participants who received treatment with regorafenib for at least 5 months and 4 months.
Characteristics, including age, sex, race, health condition, and signs and symptoms of mCRC, of participants who received treatment with regorafenib for at least 5 months and 4 months.
The data will come from an electronic health records database called the Flatiron Health Data Repository for patients in the United States. The data will be from patients with mCRC who started treatment with regorafenib between July 2013 and December 2022.
Researchers will consider the data of the participants collected until May 2023.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-term responders of regorafenib ≥5 months | – | Drug: Regorafenib (Stivarga, BAY73-4506)Defined as treatment duration ≥5 months after treatment initiation. |
| Long-term responders of regorafenib ≥4 months | – | Drug: Regorafenib (Stivarga, BAY73-4506)Defined as treatment duration ≥4 months after treatment initiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data for the study will be obtained from the Flatiron Health Data Repository; an electronic health record (EHR)-derived longitudinal demographically and geographically diverse database of oncology patients in routine clinical practice in the US. Patients with mCRC who initiated regorafenib treatment between 1 JUL 2013 and 31 DEC 2022 will be followed through the electronic data from the start of regorafenib treatment until the date of death for patients who died, and the date of last visit on or up to 31 MAY 2023 for patients with no record of death.
Key inclusion criteria (3 listed)
- Patients with a diagnosis of mCRC between 1 JAN 2013 and 31 DEC 2022 who initiated regorafenib monotherapy up to 14 days prior or after mCRC diagnosis and during the patient selection period (1 JUL 2013 to 31 DEC 2022).
- Adult patients (≥18 years old) at index date (date of first regorafenib treatment).
- Patients with at least one recorded visit, laboratory test, or other recorded electronic medical record (EMR) entry (e.g., treatment) in the Flatiron network at least 3 months prior to the index date, unless the patient was diagnosed with mCRC within the last 3 months.
Key exclusion criteria (2 listed)
- Patients who had a diagnosis or recorded history of gastrointestinal stromal tumor (GISC), hepatocellular cancer (HCC), or other primary cancers (except non-melanoma skin cancers) during the 6-month period on or prior to the index date.
- For analyses of long-term responders, patients will be excluded if treatment duration <5 and <4 months for treatment completers, or treatment duration <5 and <4 months at last visit date for non-completers.
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)Follow clinical administration. | Drug | Long-term responders of regorafenib ≥4 months, Long-term responders of regorafenib ≥5 months |
Primary outcome
Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
Time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Demographic characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
Time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Descriptive analysis of clinical characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
Time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Descriptive analysis of biomarkers of patients with mCRC who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
Time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
4 secondary outcomes
Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
Time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Demographic characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
Time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Descriptive analysis of clinical characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
Time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Descriptive analysis of biomarkers of patients with mCRC who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
Time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
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 26 Feb 2025.
- 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, timepoint 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.vivli.org 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 member 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metastatic Colorectal Cancer, run by Bayer at 1 site in United States.
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 26 Feb 2025. 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 United States. 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?
Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months (time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023). The study lists 4 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 26 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.