A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03890731|
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2019
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Cancer||Drug: BAY73-4506 (Regorafenib, Stivarga)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||April 2, 2019|
|Estimated Primary Completion Date :||November 9, 2023|
|Estimated Study Completion Date :||November 9, 2023|
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 Name: Tyrosine-kinase inhibitor
- Frequency of serious adverse events (SAEs) [ Time Frame: Up to 57 months ]
- Severity of serious adverse events (SAEs) [ Time Frame: Up to 57 months ]Severity is determined by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).
- Frequency of protocol-defined adverse events (AEs) [ Time Frame: Up to 57 months ]Comprise adverse events of CTCAE (version 5.0) grade 3 and 4, or adverse events of grade 2 if affecting vital organs
- Severity of protocol-defined adverse events (AEs) [ Time Frame: Up to 57 months ]Severity is determined by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).
- Frequency of dose modifications [ Time Frame: Up to 57 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890731
|United States, Florida|
|Tampa General Medical Group|
|Tampa, Florida, United States, 33606|
|Tübingen, Baden-Württemberg, Germany, 72076|
|Köln, Nordrhein-Westfalen, Germany, 50937|
|Firenze, Toscana, Italy, 50134|
|Saiseikai Utsunomiya Hospital|
|Utsunomiya-shi, Tochigi, Japan, 321-0974|
|Mount Vernon Hospital|
|Northwood, United Kingdom, HA6 2RN|