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

Solid Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890731
• Other study ID #: 20328
• Secondary ID: 2018-003650-24
• Status: Completed
• Phase: Phase 2
• Start date: April 2, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Cancer

Intervention

Drug:
• BAY73-4506 (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).

Locations

Country	Name	City	State
Germany	Universitätsklinikum Köln	Köln	Nordrhein-Westfalen
Germany	Eberhard-Karls-Universität Tübingen	Tübingen	Baden-Württemberg
Italy	A.O.U. Careggi	Firenze	Toscana
Japan	Saiseikai Utsunomiya Hospital	Utsunomiya-shi	Tochigi
United Kingdom	Mount Vernon Hospital	Northwood
United States	Tampa General Medical Group	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Japan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Primary	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	from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Primary	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.	from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Primary	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	from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Secondary	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)

External Links

•   Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.
•   Click here to find information about studies related to Bayer Healthcare products conducted in Europe