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

Phase 2

Completed

• Conditions: Solid Cancer
• Interventions: Drug: BAY73-4506 (Regorafenib, Stivarga)

• Registration Number: NCT03890731
• Lead Sponsor: Bayer

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Study Start: 2019-04-02
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Results First Submitted: 2024-02-07
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Results First Posted: 2024-04-02
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

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Exclusion Criteria

• Medical reasons not to start the next treatment cycle in the respective feeder
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adult patients	BAY73-4506 (Regorafenib, Stivarga)	Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment.

Primary Outcome Measures

Name	Time	Method
Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)	from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)	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
Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)	from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)	A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug.
Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs)	from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)	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.
Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)	from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)	AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (6)

Universitätsklinikum Köln; 🇩🇪 Köln, Nordrhein-Westfalen, Germany

Eberhard-Karls-Universität Tübingen; 🇩🇪 Tübingen, Baden-Württemberg, Germany

A.O.U. Careggi; 🇮🇹 Firenze, Toscana, Italy

Mount Vernon Hospital; 🇬🇧 Northwood, United Kingdom

Tampa General Medical Group; 🇺🇸 Tampa, Florida, United States

Saiseikai Utsunomiya Hospital; 🇯🇵 Utsunomiya-shi, Tochigi, Japan