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:

NCT03890731

EudraCT Number:

2018-003650-24

Recruiting

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
                - Pregnancy

Trial Summary

Enrollment Goal
50
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Active, not recruiting
 
Locations

Universitätsklinikum Köln

Köln, Germany, 50937

Status
Completed
 
Locations

Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Tampa General Medical Group

Tampa, United States, 33606

Status
Recruiting
 
Locations

Mount Vernon Hospital

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

Saiseikai Utsunomiya Hospital

Utsunomiya-shi, Japan, 321-0974

Status
Recruiting
 

Trial Design