check_circleStudy Completed

Solid cancer

Bayer Identifier:

20328

ClinicalTrials.gov Identifier:

NCT03890731

EudraCT Number:

2018-003650-24

EU CT Number:

Not Available
A clinical study of regorafenib in participants who have been treated in previous Bayer-sponsored regorafenib studies that have been completed

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.

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

Trial summary

Enrollment Goal
6
Trial Dates
April 2019 - February 2023
Phase
Phase 2
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
Universitätsklinikum KölnKöln, 50937, Germany
Completed
Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Tampa General Medical GroupTampa, 33606, United States
Completed
Mount Vernon HospitalNorthwood, HA6 2RN, United Kingdom
Completed
Saiseikai Utsunomiya HospitalUtsunomiya-shi, 321-0974, Japan

Primary Outcome

  • 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.
    date_rangeTime 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
    date_rangeTime 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.
    date_rangeTime 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
    date_rangeTime Frame:
    from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

Secondary Outcome

  • Number of participants with dose modifications
    date_rangeTime Frame:
    from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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