A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed
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.
2 other identifiers
interventional
6
5 countries
6
Brief 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. Patients participating in this study will be observed to collect information on how safe the drugs are and how this treatment is tolerated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2019
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
April 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedResults Posted
Study results publicly available
April 2, 2024
CompletedApril 2, 2024
March 1, 2024
3.9 years
March 25, 2019
February 7, 2024
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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
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.
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
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
from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Study Arms (1)
Adult patients
OTHERAdult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Medical reasons not to start the next treatment cycle in the respective feeder
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (6)
Tampa General Medical Group
Tampa, Florida, 33606, United States
Eberhard-Karls-Universität Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937, Germany
A.O.U. Careggi
Florence, Tuscany, 50134, Italy
Saiseikai Utsunomiya Hospital
Utsunomiya, Tochigi, 321-0974, Japan
Mount Vernon Hospital
Northwood, HA6 2RN, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2019
First Posted
March 26, 2019
Study Start
April 2, 2019
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
April 2, 2024
Results First Posted
April 2, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
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.