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.

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.

Study Overview

• Status: Completed
• Conditions: Solid Cancer
• Intervention / Treatment: Drug: BAY73-4506 (Regorafenib, Stivarga)

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Eberhard-Karls-Universität Tübingen
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Universitätsklinikum Köln
• Italy
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • A.O.U. Careggi
• Japan
  • Tochigi
    • Utsunomiya-shi, Tochigi, Japan, 321-0974
      • Saiseikai Utsunomiya Hospital
• United Kingdom
  • Northwood, United Kingdom, HA6 2RN
    • Mount Vernon Hospital
• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adult patients; Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment.	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).; Other Names: Tyrosine-kinase inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hepatocellular carcinoma; Renal cell cancer; Metastatic colorectal cancer (mCRC); Gastro-intestinal stromal tumor
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors
• Other Study ID Numbers: 20328; 2018-003650-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No