Solid CancerPhase 2NCT03890731
A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed
A Phase 2 study testing BAY73-4506 (Regorafenib, Stivarga) in people with Solid Cancer, run by Bayer at 6 sites in 5 countries.
Trial summary
The purpose of this study is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancer
- What is being tested?
- BAY73-4506 (Regorafenib, Stivarga)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 2 Apr 2019to 28 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be age-eligible in the feeder study at the time of signing the informed consent.
- Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving study treatment.
- Participant is currently benefiting from treatment with regorafenib monotherapy and meets criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
- Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.
Who cannot join
- Medical reasons not to start the next treatment cycle in the respective feeder
- Pregnancy
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Germany2 sites
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937
Eberhard-Karls-Universität Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: A Single Arm, Open-label, Multicenter Phase 2 Study of Regorafenib in Participants Who Have Been Treated in a Previous Bayer-sponsored Regorafenib Study (Monotherapy or Combination Treatment) That Has Reached the Primary Completion Endpoint or the Main Data Analysis, or Has Been Stopped Prematurely.
The purpose of this study is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. Patients participating in this study will be observed to collect information on how safe the drugs are and how this treatment is tolerated.
Read the detailed description
The primary objectives of the study are a) to allow patients from Bayer-sponsored trials to continue regorafenib treatment after their respective study has been completed, and b) to further assess the safety of regorafenib. Secondary objective is the documentation of drug tolerability.
- Conditions
- Solid Cancer
- Being tested
- BAY73-4506 (Regorafenib, Stivarga)
- Keywords
- Metastatic colorectal cancer (mCRC), Renal cell cancer, Gastro-intestinal stromal tumor, Hepatocellular carcinoma
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Renal Cell, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY73-4506 (Regorafenib, Stivarga)Drug
Also called Tyrosine-kinase inhibitor
Regorafenib is administered orally as 20 or 40 mg tablets at the dose that each patient received during the last cycle of the feeder trial. The dose may be either 60, 80, 120 or 160 mg once daily for 3 weeks of every 4-week cycle (3 weeks on, 1 week off).
| Study group | Role | What they receive |
|---|---|---|
| Adult patients | Other | Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment. Receives: Drug: BAY73-4506 (Regorafenib, Stivarga) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An SAE was defined as any untoward medical occurrence that, at any dose: 1. results in death 2. is life-threatening 3. requires inpatient hospitalization or prolongation of existing hospitalization, etc.
Measured: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug.
Measured: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug.
AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Secondary outcomes (1)
Number of Participants With Dose Modifications
Measured: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start2 Apr 2019
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890731
- Sponsor's protocol ID
- 20328
- Other IDs
- 2018-003650-24, 2018
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2019
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label, Multicenter Phase 2 Study of Regorafenib in Participants Who Have Been Treated in a Previous Bayer-sponsored Regorafenib Study (Monotherapy or Combination Treatment) That Has Reached the Primary Completion Endpoint or the Main Data Analysis, or Has Been Stopped Prematurely.
- ClinicalTrials.gov ID
- NCT03890731
- Acronym / sponsor ID
- 20328
- Conditions
- Solid Cancer
- Keywords
- Metastatic colorectal cancer (mCRC), Renal cell cancer, Gastro-intestinal stromal tumor, Hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Posted 2 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. Patients participating in this study will be observed to collect information on how safe the drugs are and how this treatment is tolerated.
Detailed description
The primary objectives of the study are a) to allow patients from Bayer-sponsored trials to continue regorafenib treatment after their respective study has been completed, and b) to further assess the safety of regorafenib. Secondary objective is the documentation of drug tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients | Other | Drug: BAY73-4506 (Regorafenib, Stivarga)Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must be age-eligible in the feeder study at the time of signing the informed consent.
- Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving study treatment.
- Participant is currently benefiting from treatment with regorafenib monotherapy and meets criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
- Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.
Key exclusion criteria (2 listed)
- Medical reasons not to start the next treatment cycle in the respective feeder
- Pregnancy
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 |
|---|---|---|
| BAY73-4506 (Regorafenib, Stivarga)Also: Tyrosine-kinase inhibitorRegorafenib is administered orally as 20 or 40 mg tablets at the dose that each patient received during the last cycle of the feeder trial. The dose may be either 60, 80, 120 or 160 mg once daily for 3 weeks of every 4-week cycle (3 weeks on, 1 week off). | Drug | Adult patients |
Primary outcome
Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: 1. results in death 2. is life-threatening 3. requires inpatient hospitalization or prolongation of existing hospitalization, etc.
Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug.
Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug. AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
1 secondary outcome
Number of Participants With Dose Modifications
Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
- 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.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY73-4506 (Regorafenib, Stivarga) in people with Solid Cancer, run by Bayer at 6 sites in 5 countries.
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 4 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, United States, Italy, Japan, United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)). 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 2 Apr 2024.