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

Bayer6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Cancer

Interventions

BAY73-4506 (Regorafenib, Stivarga)DRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Tampa General Medical Group

Tampa, Florida, United States

Eberhard-Karls-Universität Tübingen

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

A.O.U. Careggi

Florence, Tuscany, Italy

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

Secondary Outcomes

Number of Participants With Dose Modifications

Data from ClinicalTrials.gov

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