A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Solid Cancer

Intervention / Treatment
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* Drug: BAY73-4506 (Regorafenib, Stivarga)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adult patients<br>Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment. | Drug: BAY73-4506 (Regorafenib, Stivarga)<br>* 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).<br>* Other names: Tyrosine-kinase inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of serious adverse events (SAEs) |  | Up to 57 months | 
| Severity of serious adverse events (SAEs) | Severity is determined by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). | Up to 57 months | 
| Frequency of protocol-defined adverse events (AEs) | Comprise adverse events of CTCAE (version 5.0) grade 3 and 4, or adverse events of grade 2 if affecting vital organs | Up to 57 months | 
| Severity of protocol-defined adverse events (AEs) | Severity is determined by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). | Up to 57 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of dose modifications |  | Up to 57 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic colorectal cancer (mCRC), Renal cell cancer, Gastro-intestinal stromal tumor, Hepatocellular carcinoma