Clinical trial NCT03890731: A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Cancer
Keywords: Metastatic colorectal cancer (mCRC)
Renal cell cancer
Gastro-intestinal stromal tumor
Hepatocellular carcinoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-03-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
measure: Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
measure: Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
measure: Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Secondary outcomes:
measure: Number of Participants With Dose Modifications
timeFrame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
city: Tübingen
country: Germany
facility: Eberhard-Karls-Universität Tübingen
state: Baden-Württemberg
city: Köln
country: Germany
facility: Universitätsklinikum Köln
state: Nordrhein-Westfalen
city: Firenze
country: Italy
facility: A.O.U. Careggi
state: Toscana
city: Utsunomiya-shi
country: Japan
facility: Saiseikai Utsunomiya Hospital
state: Tochigi
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
Study officials:
References: