A Phase 2 interventional study of BAY73-4506 (Regorafenib, Stivarga) in Solid Cancer, sponsored by Bayer. Completed at 6 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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.
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.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment.
Drug: BAY73-4506 (Regorafenib, Stivarga)
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).
Also known as: Tyrosine-kinase inhibitor
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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
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)
The study was conducted in multiple centers located in 5 countries (including Germany, Japan, Italy, United Kingdom, United States), first subject first visit of the study was on 02 APR 2019 and last subject last visit was on 28 FEB 2023.
| Milestone | Regorafenib |
|---|---|
| Started | 6 |
| Completed | 0 |
| Not completed | 6 |
| Withdrew: Progressive disease | 1 |
| Withdrew: Patient's decision | 1 |
| Withdrew: Adverse event | 4 |
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.
| participants | Regorafenib |
|---|---|
| Any AE | 6 |
| - Non-serious | 6 |
| - Serious | 3 |
AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
| participants | Regorafenib |
|---|---|
| Worst grade - Grade 1 | 0 |
| Worst grade - Grade 2 | 2 |
| Worst grade - Grade 3 | 1 |
| Worst grade - Grade 4 | 3 |
| Worst grade - Grade 5 (death) | 0 |
A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug.
| participants | Regorafenib |
|---|---|
| Any AE | 5 |
| - Non-serious | 5 |
| - Serious | 1 |
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
| participants | Regorafenib |
|---|---|
| Worst grade - Grade 1 | 1 |
| Worst grade - Grade 2 | 3 |
| Worst grade - Grade 3 | 0 |
| Worst grade - Grade 4 | 1 |
| Worst grade - Grade 5 (death) | 0 |
| participants | Regorafenib |
|---|---|
| Any modification | 6 |
| Interruption/Delay | 2 |
| Drug withdrawn | 5 |
Collected over from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Regorafenib | 0/6 (0%) | 3/6 (50%) | 6/6 (100%) |
| Event | Regorafenib |
|---|---|
| PeritonitisInfections and infestations | 1/6 |
| Electrocardiogram changeInvestigations | 1/6 |
| HypocalcaemiaMetabolism and nutrition disorders | 1/6 |
| HyponatraemiaMetabolism and nutrition disorders | 1/6 |
| Renal failureRenal and urinary disorders | 1/6 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/6 |
| Event | Regorafenib |
|---|---|
| ConstipationGastrointestinal disorders | 2/6 |
| HypokalaemiaMetabolism and nutrition disorders | 2/6 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 2/6 |
| HypertensionVascular disorders | 2/6 |
| AnaemiaBlood and lymphatic system disorders | 1/6 |
| Retinal vein occlusionEye disorders | 1/6 |
| Abdominal painGastrointestinal disorders | 1/6 |
| Abdominal pain upperGastrointestinal disorders | 1/6 |
| DiarrhoeaGastrointestinal disorders | 1/6 |
| NauseaGastrointestinal disorders | 1/6 |
| Age, Continuous(years) | Regorafenib |
|---|---|
| Median | 61 (44 to 71) |
| Sex: Female, Male(Participants) | Regorafenib |
|---|---|
| Female | 3 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Regorafenib |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Regorafenib |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bayer