Trial Condition(s):
Solid cancer
A clinical study of regorafenib in participants who have been treated in previous Bayer-sponsored regorafenib studies that have been completed
Bayer Identifier:
20328
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- 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.Exclusion Criteria
- Medical reasons not to start the next treatment cycle in the respective feeder
- PregnancyTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Köln Köln, Germany, 50937 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tampa General Medical Group Tampa, United States, 33606 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mount Vernon Hospital Northwood, United Kingdom, HA6 2RN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Utsunomiya Hospital Utsunomiya-shi, Japan, 321-0974 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- 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.Timeframe: Up to 57 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) v5.0Timeframe: Up to 57 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.Timeframe: Up to 57 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) v5.0Timeframe: Up to 57 months
Secondary Outcome
- Number of participants with dose modificationsTimeframe: Up to 57 months
Additional Information
Copyright © Bayer
Powered by
