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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03890731

Enrollment

Registered

2019-03-26

Start date

2019-04-02

Completion date

2023-02-28

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Cancer

Keywords

Metastatic colorectal cancer (mCRC), Renal cell cancer, Gastro-intestinal stromal tumor, Hepatocellular carcinoma

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.

Interventions

DRUGBAY73-4506 (Regorafenib, Stivarga)

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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.
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

Secondary

Measure	Time frame
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)

Countries

Germany, Italy, Japan, United Kingdom, United States

Participant flow

Recruitment details

The study was conducted in multiple centers located in 5 countries (including Germany, Japan, Italy, United Kingdom, United States), first subject first visit of the study was on 02 APR 2019 and last subject last visit was on 28 FEB 2023.

Pre-assignment details

This was a rollover study designed to enroll participants from ongoing or future feeder studies. Overall, 6 subjects were enrolled and treated in this study.

Participants by arm

Arm	Count
Regorafenib Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.	6
Total	6

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	4
Overall Study	Patient's decision	1
Overall Study	Progressive disease	1

Baseline characteristics

Characteristic	Regorafenib
Age, Continuous	61 years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	4 Participants
Sex: Female, Male Female	3 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 6
other Total, other adverse events	6 / 6
serious Total, serious adverse events	3 / 6

Outcome results

Primary

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.